Back Clinic Chiropractic. This is a form of alternative treatment that focuses on the diagnosis and treatment of various musculoskeletal injuries and conditions, especially those associated with the spine. Dr. Alex Jimenez discusses how spinal adjustments and manual manipulations regularly can greatly help both improve and eliminate many symptoms that could be causing discomfort to the individual. Chiropractors believe among the main reasons for pain and disease are the vertebrae’s misalignment in the spinal column (this is known as a chiropractic subluxation).
Through the usage of manual detection (or palpation), carefully applied pressure, massage, and manual manipulation of the vertebrae and joints (called adjustments), chiropractors can alleviate pressure and irritation on the nerves, restore joint mobility, and help return the body’s homeostasis. From subluxations, or spinal misalignments, to sciatica, a set of symptoms along the sciatic nerve caused by nerve impingement, chiropractic care can gradually restore the individual’s natural state of being. Dr. Jimenez compiles a group of concepts on chiropractic to best educate individuals on the variety of injuries and conditions affecting the human body.
Back Pain Treatment: Louie Martinez is a business owner in El Paso, TX. After experiencing a variety of injuries which affected his ability to perform his everyday activities, Mr. Martinez chose Dr. Alex Jimenez to treat his pain. Dr. Alex Jimenez restored Louie Martinez back to his original state of health and wellness. After receiving care for over 10 years, Mr. Martinez gained his range of motion and mobility through Dr. Alex Jimenez’s thorough chiropractic care.
Back pain can affect any area of the back, including neck pain (cervical), middle back pain (thoracic), lower back pain (lumbar) or coccydynia (tailbone or sacral pain) dependent on the segment affected. The lumbar region of the back is the most common place for pain, as it supports the majority of the body’s weight. Episodes of back pain can be intense, sub-acute, or chronic depending on the duration. The pain might be characterized as a dull ache, piercing or shooting pain, or a burning sensation. Pain can radiate into the arms and hands as well as the legs or feet, and may include tingling, or weakness in the arms and legs.
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If you’ve experienced a headache, you’re not alone. Approximately 9 out of 10 individuals in the United States suffer from headaches. While some are intermittent, some frequent, some are dull and throbbing, and some cause debilitating pain and nausea, getting rid of the head pain is an immediate response for many. But, how can you most effectively relieve a headache?
Research studies have demonstrated that chiropractic care is an effective alternative treatment option for many types of headaches. A 2014 report in the Journal of Manipulative and Physiological Therapeutics (JMPT) discovered that spinal adjustments and manual manipulations used in chiropractic care improved outcome measures for the treatment of chronic and acute neck pain as well as improved the benefits of a variety of treatment approaches for neck pain. Furthermore, a 2011 JMPT study found that chiropractic care can improve and reduce the frequency of migraine and cervicogenic headaches.
How Does Chiropractic Care Treat Headaches?
Chiropractic care focuses on the treatment of a variety of injuries and/or conditions of the musculoskeletal and nervous system, including headache. A chiropractor utilizes spinal adjustments and manual manipulations to carefully correct the alignment of the spine. A subluxation, or a spinal misalignment, has been demonstrated to cause symptoms, such as neck and back pain, and headache and migraine. A balanced spine can improve spine function as well as alleviate structural stress. In addition, a doctor of chiropractic can help treat headaches and other painful symptoms by supplying nutritional advice, offering posture and ergonomics advice and recommending stress management and exercise advice. Chiropractic care can ultimately ease muscle tension along the surrounding structures of the spine, restoring the spine’s original function.
Furthermore, chiropractic care can safely and effectively treat other spinal health issues, including symptoms of neck and lower back pain due to cervical and lumbar herniated discs, among other injuries and/or conditions. A chiropractor understands how a spinal misalignment, or subluxation, can affect different areas of the body and they will treat the body as a whole rather than focusing on the symptom alone. Chiropractic treatment can help the human body naturally restore its original health and wellness.
It is well-known that chiropractic care is effective for a variety of injuries and/or conditions, however, over the last few years, research studies have found that chiropractic can enhance our well-being by managing our stress. A number of these recent research studies demonstrated that chiropractic care can alter immune function, affect heart rate, and also reduce blood pressure. A 2011 research from Japan indicated that chiropractic may have a much bigger influence on your body than you believe.
Stress is an essential indicator of health, and chronic pain symptoms can tremendously affect wellness. Researchers in Japan sought to check whether chiropractic could alter stress levels in 12 men and women with neck pain and headache. But scientists at Japan wanted to find a more objective picture of how chiropractic spinal adjustments and manual manipulations affect the nervous system, so they used PET scans to monitor brain activity and salvia trials to monitor hormone changes.
After chiropractic care, patients had altered brain activity in the areas of the brain responsible for pain processing and stress reactions. They also had significantly reduced cortisol levels, indicating decreased stress. Participants also reported lower pain scores and a greater quality of life after treatment. Mindfulness interventions, such as chiropractic care, are fundamental stress management methods and techniques. Chronic stress can lead to a variety of health issues, including neck and back pain as well as headache and migraine. Other mindfulness interventions can also safely and effectively help improve symptoms. The purpose of the following article is to demonstrate the effectiveness of another mindfulness intervention, known as mindfulness-based stress reduction, on perceived pain intensity and quality of life in patients previously diagnosed with chronic headache.
The Effectiveness of Mindfulness-Based Stress Reduction on Perceived Pain Intensity and Quality of Life in Patients With Chronic Headache
Abstract
The aim of this study was to determine the effectiveness of Mindfulness-Based Stress reduction (MBSR) on perceived pain intensity and quality of life in patients with chronic headache. Thus, forty patients based on the diagnosis of a neurologist and diagnostic criteria of the International Headache Society (IHS) for migraine and chronic tension-type headache were selected and randomly assigned to the intervention group and control group, respectively. The participants completed the Pain and quality of life (SF-36) questionnaire. The intervention group enrolled in an eight-week MBSR program that incorporated meditation and daily home practice, per week, session of 90-minutes. Results of covariance analysis with the elimination of the pre-test showed significantly improvement of pain and quality of life in the intervention group compared with the control group. The findings from this study revealed that MBSR can be used non-pharmacological intervention for improvement the quality of life and development of strategies to cope with pain in patients with chronic headache. And can be used in combination with other therapies such as pharmacotherapy.
Keywords:chronic pain, migraine headache, mindfulness, quality of life, tension headache
Dr. Alex Jimenez’s Insight
Chronic headache is a debilitating symptoms which affects many people. There are many different types of headaches, however, a majority of them often share a common trigger. Chronic stress can cause a variety of health issues of not properly managed, including muscle tension, which may lead to spinal misalignment, or subluxation, as well as other symptoms, such as neck and back pain, headaches and migraines. Stress management methods and techniques can ultimately help improve and manage stress associated symptoms. Mindfulness interventions like chiropractic care and mindfulness-based stress reduction have been determined to effectively help reduce stress and alleviate chronic headache symptoms.
Introduction
Headache is one of the most common complaints investigated in adult and pediatric neurological clinics. The vast majority of these headaches are migraine and tension-type headaches (Kurt & Kaplan, 2008). Headaches are classified into two categories of main or primary and secondary headaches. Ninety percent of headaches are primary headaches, among which migraine and tension headaches are the most common types (International Headache Society [IHS], 2013). According to the definition, migraine headache is usually unilateral and pulsating in nature and lasts from 4 to 72 hours. The associated symptoms include nausea, vomiting, increased sensitivity to light, sound and pain, and it generally increases with increasing physical activity. Also, tension headache is characterized by bilateral, non-pulsating pain, pressure or tightness, blunt pain, like a bandage or a hat, and a continuum of mild to moderate pain, preventing daily life activities (IHS, 2013).
Stovner et al. (2007) using the IHS diagnostic criteria, estimated the percentages of the adult population with an active headache disorder about 46% for headache in general, 42% for tension-type headache. This suggests that the incidence and the prevalence of tension-type headache are much higher than it was predicted. It is estimated that about 12 to 18 percent of the people have migraines (Stovner & Andree, 2010). Women are more likely to experience migraines compared to men, migraine prevalence is about 6% for men and 18% for women (Tozer et al., 2006).
Migraine and tension-type headaches are common and well-documented responses to psychological and physiological stressors (Menken, Munsat, & Toole, 2000). Migraine is a periodic and debilitating chronic pain and has a negative impact on quality of life, relationships and productivity. The World Health Organization (WHO) has announced the severe migraine as one of the most debilitating diseases with the nineteenth rank (IHS, 2013; Menken et al., 2000).
Despite the development of many medications for treatment and prevention of migraine attacks, a number of patients find them ineffective and some other find them inappropriate because of their side effects and side-effects often times lead to early discontinuation of treatment. As a result, a great interest in the development of non-pharmacologic treatments can be observed (Mulleners, Haan, Dekker, & Ferrari, 2010).
Biological factors alone cannot explain vulnerability to the experience of the headache, the onset of the attack and its course, intensified attacks of headache, headache-related disability and also the quality of life in patients with chronic headache. Negative life events are (as psychosocial factor) often known as a key factor in the development and exacerbation of headache (Nash & Thebarge, 2006).
The program of Mindfulness-Based Stress reduction (MBSR) is among the treatments, which have been studied in the past two decades on a variety of chronic pain. MBSR developed by Kabat-Zinn and used in a wide range of population with stress-related disorders and chronic pain (Kabat-Zinn, 1990). Especially in recent years, many studies have been conducted to examine the therapeutic effects of MBSR. Most studies have shown the significant effects of MBSR on different psychological conditions including the reduction of psychological symptoms of distress, anxiety, rumination, anxiety and depression (Bohlmeijer, Prenger, Taal, & Cuijpers, 2010; Carlson, Speca, Patel, & Goodey, 2003; Grossman, Niemann, Schmidt, & Walach, 2004; Jain et al., 2007; Kabat-Zinn, 1982; Kabat-Zinn, Lipworth, & Burney, 1985; Kabat-Zinn et al., 1992; Teasdale et al., 2002), pain (Flugel et al., 2010; Kabat-Zinn, 1982; Kabat-Zinn et al., 1985; La Cour & Petersen, 2015; Rosenzweig et al., 2010; Zeidan, Gordon, Merchant, & Goolkasian, 2010) and quality of life (Brown & Ryan, 2003; Carlson et al., 2003; Flugel et al., 2010; Kabat-Zinn, 1982; La Cour & Petersen, 2015; Morgan, Ransford, Morgan, Driban, & Wang, 2013; Rosenzweig et al., 2010).
Bohlmeijer et al. (2010) conducted a meta-analysis of eight randomized controlled studies on the effects of MBSR program, concluded that MBSR has small effects on depression, anxiety and psychological distress in people with chronic medical diseases. Also Grossman et al. (2004) in a meta-analysis of 20 controlled and uncontrolled studies on the effects of the MBSR program on physical and mental health of medical and non-medical samples, found an effect size of moderate for controlled studies on mental health. No effect sizes for specific symptoms such as depression and anxiety were reported. The most recent review includes 16 studies controlled and uncontrolled, This review reports that MBSR intervention decrease pain intensity, and most controlled trial studies (6 of 8) show higher reductions in pain intensity for intervention group compared with control group (Reiner, Tibi, & Lipsitz, 2013).
In another study, researchers found significant effect sizes for some subscales of quality of life for example vitality scale and bodily pain, nonsignificant effect sizes for pain and significant medium to large size effects for lower general anxiety and depression (La Cour & Petersen, 2015). Also in a study by Rosenzweig et al. (2010) on patients with chronic pain including those suffering from migraine, there were significant differences in pain intensity, pain-related functional limitations between patients. However, those suffering from migraine experienced the lowest improvement in pain and different aspects of quality of life. In general, different groups of chronic pain showed significant improvements in pain intensity and pain-related functional limitations in this study. Two other studies were conducted by Kabat-Zinn and using MBSR methods for treating patients with chronic pain, including a number of patients with chronic headaches. Statistical analysis showed a significant reduction in pain, pain interference with daily activities, medical and psychiatric signs and symptoms, anxiety and depression, negative body image, pain interference with daily activities, use of the drug and also increase in confidence (Kabat-Zinn, 1982; Kabat-Zinn et al., 1985).
Due to pain and loss of function and reduced work productivity and increased use of health care, chronic headache impose costs on individual and society, it seems that the chronic headache is a major health problem and finding ways to control and treat this problem could be of great importance. The main objective of this study was to evaluate the effectiveness of MBSR in addition to conventional pharmacotherapy in a clinical population sample of patients with chronic headache to show the effectiveness of this technique as a method of pain management and enhancement of the quality of life in patients with chronic headaches.
Methods
Participants and Procedure
This is a randomized controlled trial two- group �pretest-posttest� study design. Also an approval was obtained from the Ethics Committee of Zahedan University of Medical Sciences. The participants selected through convenience sampling method from patients with chronic migraine and tension-type headache, diagnosed by a neurologist and a psychiatrist using IHS diagnostic criteria-referred to university hospitals of Zahedan University of Medical Sciences, Zahedan-Iran.
After evaluating each patient for meeting the inclusion and exclusion criteria and taking an initial interview, 40 out of eighty-seven primary patients with chronic headache were selected and randomly assigned into two equal groups of intervention and control. Both the control and intervention groups received common pharmacotherapy under the supervision of the neurologist. During therapy sessions three subjects, due to the lack of a regular presence or exclusion criteria, opted out or were excluded from the study.
Inclusion Criteria
(1) Informed consent to participate in the sessions.
(2) Minimum age of 18 years.
(3) Minimum educational qualification of middle-school degree.
(4) The diagnosis of chronic headache (primary chronic migraine and tension-type headache) by the neurologist and according to IHS diagnostic criteria.
(5) 15 or more days per month for more than 3 months and least six months history of migraines and tension-type headache
Exclusion Criteria
(1) Subjects who were not willing to continue the participation in the study or leave the study for any reason.
(2) Other chronic pain problems.
(3) Psychosis, delirium and cognitive disorders.
(4) Cases of interpersonal difficulties interfering with teamwork.
(5) Drug and substance abuse.
(6) Mood disorder
Intervention Groups
Therapy sessions (MBSR) were held for 1.5 to 2 hours a week for the members of the intervention group (drug plus MBSR); While no MBSR was performed for the control group (only common drugs used) until the end of the research. The MBSR was carried out for 8 weeks. In this study, the 8-session MBSR program (Chaskalon, 2011) has been used. To do the meditation homework while training participants in sessions, the necessary measures have been provided in a CD and a booklet. If any one of subjects did not participate in a session or sessions, at the beginning of the next session the therapist would provide written notes of the sessions to the subjects, in addition to repeat the previous session summaries. MBSR program and discussions were presented to the patients in the eight sessions including: understanding pain and its aetiology, discuss about relationship stress, anger and emotion with pain, Understanding negative automatic thoughts, identyfying thoughts and feelings, introducing the concept of Acceptance, breathing space, three-minute breathing space, breath focus exercise, pleasant and unpleasant events daily, behavioral activation, mindfulness of routine activity, body scan practice, Seeing and hearing exercise, sitting meditation, mindful walking, reading poems related to mindfulness and also discuss how to keep up what has been developed over the whole course, discuss plans and positive reasons for maintaining the practice. Patients also received information about learning how to detect any future relapses as well as strategies and plans on which to base early detection of symptom pain attacks and for being self-directed towards new situations.
Control Group
Patients who were randomized in the control group were continuing usual pharmacotherapy(including specific and nonspecific drugs) by their neurologist until the end of the research.
Instruments
Two main tools were used in the pre-test and post-test to collect data, in addition to demographic data form. Headache log was used to determine the perceived intensity of pain using three parts: (1) 10-point likert-scale ratings, (2) the number of hours of pain per day and (3) pain frequency during the month. Each part is scored from 0 to 100, the highest level being 100. Since each patient rates their perceived pain intensity in the questionnaire, validity and reliability are not considered. And the other was a short-form 36 questionnaire (SF-36). The questionnaire is applicable in the various age groups and different diseases. The reliability and validity of the questionnaire was approved by Ware et al (Ware, Osinski, Dewey, & Gandek, 2000). The SF-36 assesses the perception of the quality of life in 8 subscales include: physical functioning (PF), role limitations due to physical health (RP), bodily pain (PB), general health (GH), energy and vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and affect health (AH). The tool has also two summary scales for Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Each scale is scored from 0 to 100, the highest functional status level being 100. The validity and reliability of the SF-36 were examined in an Iranian population. Internal consistency coefficients were between 0.70 and 0.85 for the 8 subscales and test-retest coefficients were between 0.49 and 0.79 with an interval of one week (Montazeri, Goshtasebi, Vahdaninia, & Gandek, 2005).
Data Analysis
For analyzing the data, in addition to the use of descriptive indicators, to compare the results of the intervention and control groups, the analysis of covariance was used to determine the effectiveness and the removal of the pre-test results at 95% confidence level.
Drop-Out
During therapy sessions three subjects, due to the lack of a regular presence or exclusion criteria, opted out or were excluded from the study. Thirty-seven out of 40 patients completed current study and the gathered data were then analyzed.
Results
Analysis for comparison of demographic distribution between the two groups was performed using chi-square and independent t-test. Demographic data of both groups are shown in Table 1. Distribution of age, educational years, gender and marital status were the same in each group.
Table 1: Demographic characteristics of participants.
Table 2 shows the results of analysis of covariance (ANCOVA). Levene�s test was non-significant, F (1, 35) = 2.78, P = 0.105, indicating that the assumption of homogeneity of variance had been approved. This finding shows that the variances across groups are equal and no difference was observed between two groups.
Table 2: The results of covariance analysis for the effectiveness of MBSR on pain intensity.
The main effect of MBSR intervention was significant, F (1, 34) = 30.68, P = 0.001, partial ?2 = 0.47, indicating that the pain intensity was lower after MBSR intervention (Mean = 53.89, SD.E = 2.40) than control group (Mean = 71.94, SD.E = 2.20). The covariate (pre-test of pain) was also significant, F (1, 34) = 73.41, P = 0.001, partial ?2 = 0.68, indicating that level of pain intensity before MBSR intervention had a significant effect on level of pain intensity. In other words, there was a positive relationship in the pain scores between pre-test and post-test. Therefore, the first research hypothesis is confirmed and MBSR treatment on perceived intensity was effective in patients with chronic headache and could reduce the intensity of perceived pain in these patients. All significant values are reported at p<0.05.
The second hypothesis of this study is the effectiveness of MBSR technique on quality of life in patients with chronic headache. To evaluate the effectiveness of MBSR technique on quality of life in patients with chronic headaches and eliminating the confounding variables and the effect of pre-test, for the analysis of data, multivariate covariance analysis (MANCOVA) of the dimensions of quality of life is used that Table 3 shows the results of analysis in the intervention group.
Table 3: The results of covariance analysis for the effectiveness of MBSR on quality of life.
The Table 3 shows the results of analysis of covariance (MANCOVA). The following information is needed to understand the results presented in Table 3.
The box�s test was non- significant, F = 1.08, P = 0.320, indicating that the variance�covariance matrices are the same in two groups and therefore the assumption of homogeneity is met. Also F (10, 16) = 3.153, P = 0.020, Wilks� Lambda = 0.33, partial ?2 = 0.66, indicating was a significant difference between the pre-test of the groups in the dependent variables.
Levene�s test was non-significant in some of dependent variables including [PF: F (1, 35) = 3.19, P = 0.083; RF: F (1, 35) = 1.92, P = 0.174; BP: F (1, 35) = 0.784, P = 0.382; GH: F (1, 35) = 0.659, P = 0.422; PCS: F (1, 35) = 2.371, P = 0.133; VT: F (1, 35) = 4.52, P = 0.141; AH: F (1, 35) = 1.03, P = 0.318], indicating that the assumption of homogeneity of variance had been approved in subscales of quality of life and Levene�s test was significant in some of dependent variables including [RE: F (1, 35) = 4.27, P = 0.046; SF: F (1, 35) = 4.82, P = 0.035; MCS: F (1, 35) = 11.69, P = 0.002], showing that the assumption of homogeneity of variance had been broken in subscales of quality of life.
The main effect of MBSR intervention was significant for some of dependent variables including [RP: F (1, 25) = 5.67, P = 0.025, partial ?2 = 0.18; BP: F (1, 25) = 12.62, P = 0.002, partial ?2 = 0.34; GH: F (1, 25) = 9.44, P = 0.005, partial ?2 = 0.28; PCS: F (1, 25) = 9.80, P = 0.004, partial ?2 = 0.28; VT: F (1, 25) = 12.60, P = 0.002, partial ?2 = 0.34; AH: F (1, 25) = 39.85, P = 0.001, partial ?2 = 0.61; MCS: F (1, 25) = 12.49, P = 0.002, partial ?2 = 0.33], these results indicating that subscales of RP, BP, GH, PCS, VT, AH, and MCS were higher after MBSR intervention [RP: Mean = 61.62, SD.E = 6.18; BP: Mean = 48.97, SD.E = 2.98; GH: Mean = 48.77, SD.E = 2.85; PCS: Mean = 58.52, SD.E = 2.72; VT: Mean = 44.99, SD.E = 2.81; AH: Mean = 52.60, SD.E = 1.97; MCS: Mean = 44.82, SD.E = 2.43] than control group [RP: Mean = 40.24, SD.E = 5.62; BP: Mean = 33.58, SD.E = 2.71; GH: Mean = 36.05, SD.E = 2.59; PCS: Mean = 46.13, SD.E = 2.48; VT: Mean = 30.50, SD.E = 2.56; AH: Mean = 34.49, SD.E = 1.80; MCS: Mean = 32.32, SD.E = 2.21].
Nonetheless, the main effect of MBSR intervention was non-significant for some of dependent variables including [PF: F (1, 25) = 1.05, P = 0.314, partial ?2 = 0.04; RE: F (1, 25) = 1.74, P = 0.199, partial ?2 = 0.06; SF: F (1, 25) = 2.35, P = 0.138, partial ?2 = 0.09]. These results indicating, although the means in these subscales of quality of life were higher [PF: Mean = 75.43, SD.E = 1.54; RE: Mean = 29.65, SD.E = 6.02; SF: Mean = 51.96, SD.E = 2.63] than the control group [PF: Mean = 73.43, SD.E = 1.40; RE: Mean = 18.08, SD.E = 5.48; SF: Mean = 46.09, SD.E = 2.40], But Mean difference was non-significant.
In summary, Covariance analysis (MANCOVA) results in Table 3 indicate a statistically significant difference in the scores of subscales of role limitation due to physical health (RP), bodily pain (BP), general health (GH), energy and vitality (VT), Affect health (AH) and sum of physical health dimensions (PCS) and mental health (MCS). And also indicates that there was not a statistically significant difference in subscale scores of physical functioning (PF), role limitations due to emotional problems (RE) and social functioning (SF) in the intervention group. All significant values are reported at p<0.05.
Discussion
This study aimed to evaluate the effectiveness of MBSR on perceived pain intensity and quality of life in patients with chronic headache. The results showed that MBSR treatment was significantly effective on reduction of pain intensity perception. The results of current study are consistent with the results of other researchers who had used the same method for chronic pain (e.g. Flugel et al., 2010; Kabat-Zinn, 1982; Kabat-Zinn et al., 1985; La Cour & Petersen, 2015; Reibel, Greeson, Brainard, & Rosenzweig, 2001; Reiner et al., 2013; Rosenzweig et al., 2010; zeidan et al., 2010). For example, in two studies conducted by Kabat-Zinn, where the MBSR program was used for treating patients with chronic pain by physicians, a number of patients with chronic headache were also included. The first study of the two studies, showed a significant reduction in pain, pain interference with daily activities, medical signs and psychiatric disorders, including anxiety and depression (Kabat-Zinn, 1982). The results of second study showed significant reduction in pain, negative body image, anxiety, depression, pain interference with daily activities, medical symptoms, medication use, and also showed an increase in self-confidence (Kabat-Zinn et al., 1985).
Also, the findings of the current study are consistent with the results of Rosenzweig et al. (2010), their results suggest that MBSR program is effective for reduction, physical pain, quality of life and psychological well-being of patients with various chronic pains and mindfulness is effective on emotional and sensory components of pain perception by self-regulation of attention through meditation activities. Although the results of Rosenzweig et al. (2010) showed that among patients with chronic pain the minimal impact on the reduction in bodily pain and improvement in quality of life was related to patients with fibromyalgia, chronic headache. In another study conducted by Flugel et al. (2010), although positive changes were observed in the frequency and the intensity of pain, the pain reduction was not statistically significant.
In another study, pain severity significantly reduced after the intervention in patients with tension headache. In addition, the MBSR group showed higher scores in mindful awareness in comparison with the control group (Omidi & Zargar, 2014). In a pilot study by Wells et al. (2014), their results showed that MBSR with pharmacological treatment was possible for patients with migraines. Although the small sample size of this pilot study did not provide power to detect a significant difference in the pain severity and migraine frequency, results demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy.
In explaining the results of the effectiveness of mindfulness based therapies for pain it can be said, psychological models of chronic pain such as fear-avoidance model showed that the ways by which people interpret their feelings of pain and respond to them are important determinants in the experience of pain (Schutze, Rees, Preece, & Schutze, 2010). Pain catastrophizing is significantly associated with fear and anxiety caused by pain, the cognitive paths through which the fear of pain can be caused and also the pain-related disability is associated and also because the negative cognitive assessment of pain explains 7 to 31% of the variance of the pain intensity. Therefore, any mechanism that can reduce pain catastrophizing or make changes in its process can reduce the perception of pain intensity and the disability caused by that. Schutz et al. (2010) argue that the little mindfulness is the primer of pain catastrophizing. In fact, it seems that the tendency of the individual to engage in the automatic processing processes rather than knowledge-based processes with attention of insufficient flexibility, and lack of awareness of the present moment (Kabat-Zinn, 1990), will cause people to think more about the pain and thus overestimate the resulting risk of it. Thus, little mindfulness allows for the development of negative cognitive evaluation of the pain (Kabat-Zinn, 1990).
Another possible reason may be that the pain acceptance and readiness for change increase positive emotions, leading to a reduction in pain intensity through effects on the endocrine system and the production of endogenous opioids and reduction in pain-related disability or preparing individuals for the use of effective strategies to deal with pain (Kratz, Davis, & Zautra, 2007). Another possible reason to explain the results of the present study in its effectiveness on pain reduction can be the fact that chronic pain is developed due to an overactive stress response system (Chrousos & Gold, 1992). The result is the disturbing of the physical and mental processes. Mindfulness can allow for the access to the frontal cortex and improve it, brain areas that integrate physical and mental functions (Shapiro et al., 1995). The result is the creation of a little stimulation that reduces the intensity and the experience of physical and mental pain. Thus, pain impulses are experienced as feeling of the real pain rather than a negative recognition. The result is the closing of the pain channels that can reduce pain (Astin, 2004).
Mindfulness meditation Reduces Pain Through several Brain Mechanisms and various pathways such as changing of attention in meditation practices might impress both sensory and affective components of pain perception. On the other hand, mindfulness reduces the reactivity to distressing thoughts and feelings that accompany pain perception and strengthen the pain. Also, mindfulness reduces psychological symptoms such as comorbid anxiety and depression and increases parasympathetic activity, which can promote deep muscle relaxation that may reduce pain. Finally, mindfulness may decrease stress and mood dysfunction-related psychophysiologic activation by strengthening reframing negative situation and self-regulation skills. Higher level of mindfulness predicted lower levels of anxiety, depression, catastrophic thinking and disability. Other research has showed that mindfulness has an important role in cognitive and emotional control, and may be useful in reframing negative situations (Zeidan et al., 2011; Zeidan, Grant, Brown, McHaffie, & Coghill, 2012).
The second aim of this study was to determine the effectiveness of the MBSR program on quality of life in patients with chronic headache. This study showed that this treatment was significantly effective on quality of life dimensions, including role limitations due to health status, bodily pain, general health, energy and vitality, emotional health and overall physical and mental health scales. However, the MBSR program could not significantly increase the quality of life in physical functioning, role limitations due to emotional problems and social functioning. It seems apparent from previous and current studies and as well as from the present study that MBSR no effect on physical and social functions. This is likely because that the effects on pain levels in patients with headache are small, and that change is slow. On the other hand, patients with chronic pain have often learned to ignore pain in order to function normally (La Cour & Petersen, 2015). Although, the changes have been in the desired direction and increased the mean scores of the intervention group compared with the control group. These findings are consistent with previous findings (Brown & Ryan, 2003; Carlson et al., 2003; Flugel et al., 2010; Kabat-Zinn, 1982; La Cour & Petersen, 2015; Morgan et al., 2013; Reibel et al., 2001; Rosenzweig et al., 2010).
With regard to the content of the MBSR sessions, this program emphasizes the application of techniques to reduce stress, deal with pain and the awareness of the situation. Giving up the fight and accepting the present situation, without judgment, is the main concept of the program (Flugel et al., 2010). In fact, changes in acceptance without judgment are associated with improvement in quality of life (Rosenzweig et al., 2010). MBSR is aimed to increase awareness of the present moment. The treatment plan is a new and personal way to deal with stress to the individual. External stressors are part of life and cannot be changed, but coping skills and how to respond to the stress can be changed (Flugel et al., 2010). McCracken and velleman (2010) showed that cognitive flexibility and higher mindfulness is associated with less suffering and disability in patients. Patients with chronic pain with higher levels of mindfulness reported less depression, stress, anxiety and pain and also improvement in the self-efficacy and quality of life. Morgan et al. (2013) studying arthritis patients achieved similar results, so that patients with higher levels of mindfulness reported lower stress, depression and higher self-efficacy and quality of life. As noted above it was expected that pain reduction in patients leads to reduced fear and anxiety associated with pain and thereby reduces the resulting functioning limitations. Also, the results of the several studies (Cho, Heiby, McCracken, Lee, & Moon, 2010; McCracken, Gauntlett-Gilbert, & Vowles, 2007; Rosenzweig et al., 2010; Schutz et al., 2010) confirm this finding.
Several studies have been done to evaluate the effectiveness of different types of mindfulness-based treatments on chronic pain, including patients with headache. Unlike other research that examined heterogeneous sets of patients with chronic pain, the advantage of this study is that, it has been only performed on patients with chronic headache.
In the end, it should be acknowledged that there are some limitations in this study such as small sample size, lack of a long-term follow-up program, participants� medication use and arbitrary treatments; and despite the efforts of researchers, the lack of fully similar pharmacotherapy for all participants can confound the test results and make it difficult to generalize the results. Since the present study is the first of its type in patients with chronic headache in Iran, it is suggested that similar studies should be carry out in this field, with larger sample sizes as possible. And further studies investigate the stability of the treatment results in long-term follow-up periods of time.
Conclusion
According to the findings of this study it can be concluded that MBSR methods generally are effective on perceived pain intensity and quality of life of patients with chronic headache. Although there was no statistically significant difference in some aspects of quality of life, such as physical functioning, role limitations due to emotional problems and social functioning, but overall changes in mean were desired to the study. Thus the integrating of MBSR treatment with conventional medical therapy in the treatment protocol for patients with chronic headache can be advised. The researcher also believes that despite the shortcomings and deficiencies of current research, this study could be a new approach to the treatment of chronic headache and could provide a new horizon in this field of treatment.
Acknowledgements
This research was supported (as a thesis) in part by Zahedan University of Medical Sciences. We would like to thank all participants in the study, local healers, the staff of hospitals- Ali -ebn-abitaleb, Khatam-al-anbia and Ali asghar- for their support and help.
In conclusion,�chiropractic care is a safe and effective alternative treatment option utilized to help improve as well as manage chronic headache symptoms by carefully and gently realigning the spine as well as providing stress management methods and techniques. Because stress has been associated with a variety of health issues, including subluxation, or misalignment of the spine, and chronic headache, mindfulness interventions like chiropractic care and mindfulness-based stress reduction (MBSR) are fundamental towards chronic headache. Finally, the article above demonstrated that MBSR can be effectively used as a mindfulness intervention for chronic headache and to improve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Back Pain
According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.
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Carpal Tunnel Pain: Ottis Hamlet depends largely on the use of his hands to carry out his important craftsmanship in the city of San Antonio, TX. However, Mr. Hamlet developed painful symptoms in both of his arms as a result of carpal tunnel syndrome, which tremendously affected his ability to engage in his job. Fortunately, Ottis Hamlet met Dr. Alex Jimenez during a visit to El Paso, TX and he received chiropractic treatment for his carpal tunnel syndrome, avoiding the need for surgery.
Carpal tunnel syndrome is a medical condition caused by the compression of the median nerve which travels through the wrist and into the carpal tunnel. Common symptoms include pain, tingling sensations and numbness, in the thumb, index finger, middle finger, and the thumb side of the ring fingers. Symptoms normally start gradually and during the evening. Symptoms can extend throughout the arm and weakened grip strength may also occur. Carpal tunnel syndrome can be diagnosed based on symptoms.
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Being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. Auto accident injuries, such as whiplash, can be characterized by painful symptoms, including chronic neck pain, however, recent research studies have found that emotional distress resulting from an auto collision could manifest into physical symptoms. Stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident.
The researchers of the research studies also determined that cognitive-behavioral therapy may be an effective treatment for emotional distress and psychological issues which may have developed as a result of the auto accident injuries. Additionally, auto accident injuries may also cause stress, anxiety, depression and even PTSD if left untreated for an extended amount of time. The purpose of the article below is to demonstrate the effects of cognitive-behavioral therapy, together with alternative treatment options like chiropractic care and physical therapy. for auto accident injuries, such as whiplash.
Neck Exercises, Physical and Cognitive Behavioural-Graded Activity as a Treatment for Adult Whiplash Patients with Chronic Neck Pain: Design of a Randomised Controlled Trial
Abstract
Background
Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline.
Methods/Design
The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg – 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.
Discussion
The perspectives of this study are discussed, in addition to the strengths and weaknesses.
The Danish National Board of Health estimates that 5-6,000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced neck pain. About 43% of those will still have physical impairment and symptoms 6 months after the accident [1]. For Swedish society, including Swedish insurance companies, the economic burden is approximately 320 million Euros [2], and this burden is likely to be comparable to that of Denmark. Most studies suggest that patients with Whiplash-Associated Disorders (WAD) report chronic neck symptoms one year after the injury [3]. The main problems in whiplash patients with chronic neck pain are cervical dysfunction and abnormal sensory processing, reduced neck mobility and stability, impaired cervicocephalic kinaesthetic sense, in addition to local and possibly generalised pain [4,5]. Cervical dysfunction is characterised by reduced function of the deep stabilising muscles of the neck.
Besides chronic neck pain, patients with WAD may suffer from physical inactivity as a consequence of prolonged pain [6,7]. This influences physical function and general health and can result in a poor quality of life. In addition, WAD patients may develop chronic pain followed by sensitisation of the nervous system [8,9], a lowering of the threshold for different sensory inputs (pressure, cold, warm, vibration and electrical impulses) [10]. This can be caused by an impaired central pain inhibition [11] – a cortical reorganisation [12]. Besides central sensitisation, the group with WAD may have poorer coping strategies and cognitive functions, compared with patients with chronic neck pain in general [13-15].
Studies have shown that physical training, including specific exercises targeting the deep postural muscles of the cervical spine, is effective in reducing neck pain [16-18] for patients with chronic neck pain, albeit there is a variability in the response to training with not every patient showing a major change. Physical behavioural-graded activity is a treatment approach with a focus on increasing general physical fitness, reducing fear of movement and increasing psychological function [19,20]. There is insufficient evidence for the long-term effect of treatment of physical and cognitive behavioural-graded activity, especially in chronic neck pain patients. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies, have shown reduced general pain [6,21-26]. A review indicated that interventions with a combination of cognitive, behavioural therapy with physiotherapy including neck exercises is effective in the management of WAD patients with chronic neck pain [27], as also recommended by the Dutch clinical guidelines for WAD [28]. However, the conclusions regarding the guidelines are largely based on studies performed on patients with either acute or sub-acute WAD [29]. A more strict conclusion was drawn for WAD patients with chronic pain in the Bone and Joint Decade 2000-2010 Task Force, stating, that ‘because of conflicting evidence and few high-quality studies, no firm conclusions could be drawn about the most effective non-invasive interventions for patients with chronic WAD” [29,30]. The concept of combined treatment for WAD patients with chronic pain has been used in a former randomised controlled trial [31]. The results indicated that a combination of non-specific aerobic exercises and advice containing standardised pain education and reassurance and encouragement to resume light activity, produced better outcomes than advice alone for patients with WAD 3 months after the accident. The patients showed improvements in pain intensity, pain bothersomeness and functions in daily activities in the group receiving exercise and advice, compared with advice alone. However, the improvements were small and only apparent in the short term.
This project is formulated on the expectation that rehabilitation of WAD patients with chronic neck pain must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach. Each single intervention is based upon former studies that have shown effectiveness [6,18,20,32]. This study is the first to also include the long-term effect of the combined approach in patients with chronic neck pain after whiplash trauma. As illustrated in Figure ?Figure1,1, the conceptual model in this study is based upon the hypothesis that training (including both individually-guided specific neck exercises and graded aerobic training) and education in pain management (based on a cognitive behavioural approach) is better for increasing the patients’ physical quality of life, compared with education in pain management alone. Increasing the physical quality of life includes increasing the general physical function and level of physical activity, decreasing fear of movement, reducing post-traumatic stress symptoms, reducing neck pain and increasing neck function. The effect is anticipated to be found immediately after the treatment (i.e. 4 months; short-term effect) as well as after one year (long-term effect).
Figure 1: Hypothesis of the intervention effect for patients with chronic neck pain after a whiplash accident.
Using a randomised controlled trial (RCT) design, the aim of this study is to evaluate the effectiveness of: graded physical training, including specific neck exercises and general aerobic training, combined with education in pain management (based on a cognitive behavioural approach) versus education in pain management (based on a cognitive behavioural approach), measured on physical quality of life’, physical function, neck pain and neck functions, fear of movement, post-traumatic symptoms and mental quality of life, in patients with chronic neck pain after whiplash injury.
Methods/Design
Trial Design
The study is conducted in Denmark as an RCT with a parallel group design. It will be a two-centre study, stratified by recruitment location. Patients will be randomised to either the Pain Management group (control) or the Pain Management and Training group (intervention). As illustrated in Figure ?Figure2,2, the study is designed to include a secondary data assessment 12 months after baseline; the primary outcome assessment will be performed immediately after the intervention program 4 months after baseline. The study utilises an allocation concealment process, ensuring that the group to which the patient is allocated is not known before the patient is entered into the study. The outcome assessors and data analysts will be kept blinded to the allocation to intervention or control group.
Figure 2: Flowchart of the patients in the study.
Settings
The participants will be recruited from physiotherapy clinics in Denmark and from The Spine Centre of Southern Denmark, Hospital Lilleb�lt via an announcement at the clinics and the Hospital. Using physiotherapy clinics spread across Denmark, the patients will receive the intervention locally. The physiotherapy clinics in Denmark receive patients via referral from their general practitioners. The Spine Centre, a unit specialising in treating patients with musculoskeletal dysfunctions and only treating out-patients, receives patients referred from general practitioners and/or chiropractors.
Study Population
Two hundred adults with a minimum age of 18 years, receiving physiotherapy treatment or having been referred for physiotherapy treatment will be recruited. For patients to be eligible, they must have: chronic neck pain for at least 6 months following a whiplash injury, reduced physical neck function (Neck Disability Index score, NDI, of a minimum of 10), pain primarily in the neck region, finished any medical /radiological examinations, the ability to read and understand Danish and the ability to participate in the exercise program. The exclusion criteria include: neuropathies/ radiculopathies (clinically tested by: positive Spurling, cervical traction and plexus brachialis tests) [33], neurological deficits (tested as in normal clinical practice through a process of examining for unknown pathology), engagement in experimental medical treatment, being in an unstable social and/or working situation, pregnancy, known fractures, depression according to the Beck Depression Index (score > 29) [18,34,35], or other known coexisting medical conditions which could severely restrict participation in the exercise program. The participants will be asked not to seek other physiotherapy or cognitive treatment during the study period.
Intervention
Control
The Pain Management (control) group will receive education in pain management strategies. There will be 4 sessions of 11/2 hours, covering topics regarding pain mechanisms, acceptance of pain, coping strategies, and goal-setting, based upon pain management and cognitive therapy concepts [21,26,36].
Intervention
The Pain Management plus Training (intervention) group will receive the same education in pain management as those in the control group plus 8 treatment sessions (instruction in neck exercises and aerobic training) with the same period of 4 months length. If the treating physiotherapist estimates additional treatments are needed, the treatment can be extended with 2 more sessions. Neck training: The treatment of neck-specific exercises will be progressed through different phases, which are defined by set levels of neck function. At the first treatment session, patients are tested for cervical neuromuscular function to identify the specific level at which to start neck training. A specific individually tailored exercise program will be used to target the neck flexor and extensor muscles. The ability to activate the deep cervical neck flexor muscles of the upper cervical region to increase their strength, endurance and stability function is trained progressively via the craniocervical training method using a biopressure feedback transducer [18,37]. Exercises for neck-eye coordination, neck joint positioning, balance and endurance training of the neck muscles will be included as well, since it has been shown to reduce pain and improve sensorimotor control in patients with insidious neck pain [17,38]. Aerobic training: The large trunk and leg muscles will be trained with a gradually increasing physical training program. Patients will be allowed to select activities such as walking, cycling, stick walking, swimming, and jogging. The baseline for training duration is set by exercising 3 times at a comfortable level, that does not exacerbate pain and aims at a rated perceived exertion (RPE) level of between 11 and 14 on a Borg scale [39]. The initial duration of training is set 20% below the average time of the three trials. Training sessions are carried out every second day with a prerequisite that pain is not worsened, and that RPE is between 9 and 14. A training diary is used. If patients do not experience a relapse, and report an average RPE value of 14 or less, the exercise duration for the following period (1 or 2 weeks) is increased by 2-5 minutes, up to a maximum of 30 minutes. If the RPE level is 15 or higher, the exercise duration will be reduced to an average RPE score of 11 to 14 every fortnight [20,40]. By using these pacing principles, the training will be graded individually by the patient, with a focus on perceived exertion – with the aim of increasing the patient’ s general physical activity level and fitness.
Patients’ compliance will be administered by registration of their participation in the control and intervention group. The patients in the control group will be considered to have completed the pain management if they have attended 3 out of 4 sessions. The patiesnts in the intervention group will be considered to have completed if the patient has attended a minimum of 3 out of 4 pain management sessions and a minimum of 5 out of 8 trainings sessions. Each patient’s home training with neck exercises and aerobic training will be registered by him/her in a logbook. Compliance with 75% of the planned home training will be considered as having completed the intervention.
Physiotherapists
The participating physiotherapists will be recruited via an announcement in the Danish Physiotherapy Journal. The inclusion criteria consist of: being a qualified physiotherapist, working at a clinic and having at least two years of working experience as a physiotherapist, having attended a course in the described intervention and passed the related exam.
Outcome Measures
At baseline the participants’ information on age, gender, height and weight, type of accident, medication, development of symptoms over the last two months (status quo, improving, worsening), expectation of treatment, employment and educational status will be registered. As a primary outcome measure, Medical Outcomes Study Short Form 36 (SF36) – Physical Component Summary (PCS) will be used [41,42]. The PCS scales are scored using norm-based methods [43,44] with a mean score of 50 with a standard deviation of 10. The primary outcome with respect to having an effect, will be calculated as a change from baseline [45]. Secondary outcomes contain data on both clinical tests and patient-reported outcomes. Table ?Table11 presents clinical tests for measuring the intervention effect on neuromuscular control of the cervical muscles, cervical function and mechanical allodynia. Table ?Table22 presents the patient-related outcomes from questionnaires used to test for perceived effect of the treatment, neck pain and function, pain bothersomeness, fear of movement, post-traumatic stress and quality of life and potential treatment modifiers.
Table 1: Clinical outcomes used for measurement of treatment effect on muscle strategy, function and treatment modifiers.
Table 2: Patient reported outcomes used for measured of treatment effect on pain and function.
Patients will be tested at baseline, 4 and 12 months after baseline, except for GPE, which will only be measured 4 and 12 months after baseline.
Power and Sample Size Estimation
The power and sample size calculation is based on the primary outcome, being SF36-PCS 4 months after baseline. For a two-sample pooled t-test of a normal mean difference with a two-sided significance level of 0.05, assuming a common SD of 10, a sample size of 86 per group is required to obtain a power of at least 90% to detect a group mean difference of 5 PCS points [45]; the actual power is 90.3%, and the fractional sample size that achieves a power of exactly 90% is 85.03 per group. In order to adjust for an estimated 15% withdrawal during the study period of 4 months, we will include 100 patients in each group. For sensitivity, three scenarios were applied: firstly, anticipating that all 2 � 100 patients complete the trial, we will have sufficient power (> 80%) to detect a group mean difference as low as 4 PCS points; secondly, we will be able to detect a statistically significant group mean difference of 5 PCS points with sufficient power (> 80%) even with a pooled SD of 12 PCS points. Thirdly and finally, if we aim for a group mean difference of 5 PCS points, with a pooled SD of 10, we will have sufficient power (> 80%) with only 64 patients in each group. However, for logistical reasons, new patients will no longer be included in the study 24 months after the first patient has been included.
Randomisation, Allocation and Blinding Procedures
After the baseline assessment, the participants are randomly assigned to either the control group or the intervention group. The randomisation sequence is created using SAS (SAS 9.2 TS level 1 M0) statistical software and is stratified by centre with a 1:1 allocation using random block sizes of 2, 4, and 6. The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminium foil inside the envelope will be used to render the envelope impermeable to intense light. After revealing the content of the envelope, both patients and physiotherapists are aware of the allocation and the corresponding treatment. Outcome assessors and data analysts are however kept blinded. Prior to the outcome assessments, the patients will be asked by the research assistant not to mention the treatment to which they have been allocated.
Statistical Analysis
All the primary data analyses will be carried out according to a pre-established analysis plan; all analyses will be done applying SAS software (v. 9.2 Service Pack 4; SAS Institute Inc., Cary, NC, USA). All descriptive statistics and tests are reported in accordance with the recommendations of the ‘Enhancing the QUAlity and Transparency Of health Research’ (EQUATOR) network; i.e., various forms of the CONSORT statement [46]. Data will be analysed using a two-factor Analysis of Covariance (ANCOVA), with a factor for Group and a factor for Gender, using the baseline value as covariate to reduce the random variation, and increase the statistical power. Unless stated otherwise, results will be expressed as the difference between the group means with 95% confidence intervals (CIs) and associated p-values, based on a General Linear Model (GLM) procedure. All the analyses will be performed using the Statistical Package for Social Sciences (version 19.0.0, IBM, USA) as well as the SAS system (v. 9.2; SAS Institute Inc., Cary, NC, USA). A two-way analysis of variance (ANOVA) with repeated measures (Mixed model) will be performed to test the difference over time between the intervention and the control groups; interaction: Group � Time. An alpha-level of 0.05 will be considered as being statistically significant (p < 0.05, two- sided). The data analysts will be blinded to the allocated interventions for primary analyses.
The baseline scores for the primary and secondary outcomes will be used to compare the control and intervention groups. The statistical analyses will be performed on the basis of the intention-to-treat principle, i.e. patients will be analysed in the treatment group to which they were randomly allocated. In the primary analyses, missing data will be replaced with the feasible and transparent ‘Baseline Observation Carried Forward’ (BOCF) technique, and for sensitivity also a multiple imputation technique will apply.
Secondarily, to relate the results to compliance, a ‘per protocol’ analysis will be used as well. The ‘per protocol’ population he patients who have ‘completed’ the intervention to which they were allocated, according to the principles described in the intervention section above.
Ethical Considerations
The Regional Scientific Ethical Committee of Southern Denmark approved the study (S-20100069). The study conformed to The Declaration of Helsinki 2008 [47] by fulfilling all general ethical recommendations.
All subjects will receive information about the purpose and content of the project and give their oral and written consent to participate, with the possibility to drop out of the project at any time.
Dr. Alex Jimenez’s Insight
Managing stress, anxiety, depression and symptoms of post traumatic stress disorder, or PTSD, after being involved in an automobile accident can be difficult, especially if the incident caused physical trauma and injuries or aggravated a previously existing condition. In many cases, the emotional distress and the psychological issues caused by the incident may be the source of the painful symptoms. In El Paso, TX, many veterans with PTSD visit my clinic after manifesting worsening symptoms from a previous auto accident injury. Chiropractic care can provide patients the proper stress management environment they need to improve their physical and emotional symptoms. Chiropractic care can also treat a variety of auto accident injuries, including whiplash, head and neck injuries, herniated disc and back injuries.
Discussion
This study will contribute to a better understanding of treating patients with chronic neck pain following a whiplash accident. The knowledge from this study can be implemented into clinical practice, as the study is based on a multimodal approach, mirroring the approach, which in spite of the current lack of evidence, is often used in a clinical physiotherapy setting. The study may also be included in systematic reviews thereby contributing to updating the knowledge about this population and to enhancing evidence-based treatment.
Publishing the design of a study before the study is performed and the results obtained has several advantages. It allows the design to be finalised without its being influenced by the outcomes. This can assist in preventing bias as deviations from the original design can be identified. Other research projects will have the opportunity to follow a similar approach with respect to population, interventions, controls and outcome measurements. The challenges of this study are related to standardising the interventions, treating a non-homogeneous population, defining and standardising relevant outcome measures on a population with long-lasting symptoms and having a population from two different clinical settings. Standardisation of the interventions is obtained by teaching the involved physiotherapists in an instructional course. Population homogeneity will be handled by strict inclusion and exclusion criteria and by monitoring the baseline characteristics of the patients, and differences between groups based on other influences than the intervention/control will be possible to analyse statistically. This research design is composed as an ‘add-on’ design: both groups receive pain education; the intervention group receives additional physical training, including specific neck exercises and general training. Today there is insufficient evidence for the effect of treatment for patients with chronic neck pain following a whiplash accident. All participating patients will be referred for a treatment (control or intervention), as we consider it unethical not to offer some form of treatment, i.e. randomising the control group to a waiting list. The add-on design is chosen as a pragmatic workable solution in such a situation [48].
For whiplash patients with chronic pain, the most responsive disability measures (for the individual patient, not for the group as a whole) are considered to be the Patient Specific Functional Scale and the numerical rating scale of pain bothersomeness [49]. By using these and NDI (the most often used neck disability measure) as secondary outcome measures, it is anticipated that patient-relevant changes in pain and disability can be evaluated. The population will be recruited from and treated at two different clinical settings: the out-patient clinic of The Spine Centre, Hospital Lilleb�lt and several private physiotherapy clinics. To avoid any influence of the different settings on the outcome measures, the population will be block randomised related to the settings, securing equal distribution of participants from each setting to the two intervention groups.
Competing Interests
The authors declare that they have no competing interests.
Authors’ Contributions
IRH drafted the manuscript. IRH, BJK and KS participated in the design of the study. All contributed to the design. RC, IRH; BJK and KS participated in the power and sample size calculation and in describing the statistical analysis as well as the allocation and randomization procedure. All authors read and approved the final manuscript. Suzanne Capell provided writing assistance and linguistic corrections.
This study has received funding from the Research Fund for the Region of Southern Denmark, the Danish Rheumatism Association, the Research Foundation of the Danish Association of Physiotherapy, the Fund for Physiotherapy in Private Practice, and the Danish Society of Polio and Accident Victims (PTU). The Musculoskeletal Statistics Unit at the Parker Institute is supported by grants from the Oak Foundation. Suzanne Capell provided writing assistance and linguistic correction.
A Randomized Controlled Trial of Cognitive-Behavioral Therapy for the Treatment of PTSD in the context of Chronic Whiplash
Abstract
Objectives
Whiplash-associated disorders (WAD) are common and involve both physical and psychological impairments. Research has shown that persistent posttraumatic stress symptoms are associated with poorer functional recovery and physical therapy outcomes. Trauma-focused cognitive-behavioral therapy (TF-CBT) has shown moderate effectiveness in chronic pain samples. However, to date, there have been no clinical trials within WAD. Thus, this study will report on the effectiveness of TF-CBT in individuals meeting the criteria for current chronic WAD and posttraumatic stress disorder (PTSD).
Method
Twenty-six participants were randomly assigned to either TF-CBT or a waitlist control, and treatment effects were evaluated at posttreatment and 6-month follow-up using a structured clinical interview, self-report questionnaires, and measures of physiological arousal and sensory pain thresholds.
Results
Clinically significant reductions in PTSD symptoms were found in the TF-CBT group compared with the waitlist at postassessment, with further gains noted at the follow-up. The treatment of PTSD was also associated with clinically significant improvements in neck disability, physical, emotional, and social functioning and physiological reactivity to trauma cues, whereas limited changes were found in sensory pain thresholds.
Discussion
This study provides support for the effectiveness of TF-CBT to target PTSD symptoms within chronic WAD. The finding that treatment of PTSD resulted in improvements in neck disability and quality of life and changes in cold pain thresholds highlights the complex and interrelating mechanisms that underlie both WAD and PTSD. Clinical implications of the findings and future research directions are discussed.
In conclusion, being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. However, stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident. According to research studies, physical symptoms and emotional distress may be closely connected and treating both physical and emotional injuries could help patients achieve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Back Pain
According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.
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Sciatica Nerve Pain:�Edgar M. Reyes works for the city of El Paso and his ability to properly engage in his occupation is an essential part of his job, however, Mr. Reyes developed sciatica, which affected his everyday performance. Unable to walk due to his sciatica nerve pain, Edgar M Reyes found chiropractic treatment with Dr. Alex Jimenez. Chiropractic care provided Mr. Reyes with the relief he deserved from his sciatica and restored his ability to walk as well as his health and wellness.
Sciatica is a set of symptoms characterized by radiating pain from the lumbar spine. This pain may go down the back, into the buttocks, hips, legs and feet. Onset is frequently sudden following tasks like heavy lifting, though slow onset may also occur. Symptoms may occur on one or both sides of the body. Pain, numbness and weakness can occur depending on the type of compression on the sciatic nerve. About 90% of sciatica cases are often due to a spinal disc herniation pressing on one of the lumbar or sacral nerve roots. Other issues that may cause sciatica include spondylolisthesis, spinal stenosis and piriformis syndrome.
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When you’ve been involved in a car crash, the auto accident injuries resulting from the incident may not always have a physical cause. The emotional distress due to trauma or injury from the impact of an automobile accident may often be so immense, it can lead to a variety of painful symptoms. If such stress is not treated immediately, it could result in the development of psychological conditions. Stress, anxiety, depression and in severe cases, PTSD, or post traumatic stress disorder, are some of the most common psychological issues you may end up encountering after a traumatic auto accident.
Anxiety and Irrational Fears
In several cases, the victim of an automobile accident may develop irrational fears as a result of the incident. As a matter of fact, many of these individuals report experiencing anxiety about getting behind the wheel again. For them, the fear of being in another accident may ultimately cause them to avoid driving altogether. For many other individuals still, the irrational fear of suffering a panic attack while on the road may be the cause for them to avert driving entirely. If the anxiety and irrational fears caused by the emotional distress of an auto accident worsen, it may permanently�discourage a person from driving again.
Depression
It is also possible for people who’ve been involved in an auto accident to develop depression following the incident. In the end, you wind up experiencing psychological trauma as a result of physical trauma. There are numerous symptoms of depression which you might readily recognize. These include problems with sleep, losing your appetite, and headaches. As it becomes worse, however, you might end up feeling sad or hopeless all of the time, which could lead to worsening symptoms.
Post Traumatic Stress Disorder (PTSD)
It’s highly possible for individuals involved in an automobile accident to suffer from post traumatic stress disorder, or PTSD. According to the National Center For PTSD, as much as 9 percent of people who experience auto accident injuries end up suffering from PTSD. Moreover, at least 14 percent of car crash survivors who seek mental health care are experiencing PTSD.
A new research study demonstrated that mindfulness interventions might be just as essential to your health as traditional treatment, especially if you’ve got post traumatic stress disorder, or PTSD. Researchers have demonstrated that chiropractic care can lead to a substantial advancement in the mind-body stress component of a patient’s overall health and wellness.
Chiropractic Care for Auto Accident Injuries
Addressing automobile accident injuries, such as whiplash, which also result in anxiety and irrational fears, depression and especially PTSD, demands a multi-disciplinary strategy. Chiropractic is an alternative treatment option which focuses on injuries and/or conditions of the musculoskeletal and nervous system. A chiropractor commonly utilizes spinal adjustments and manual manipulations to carefully correct spinal misalignments, or subluxations, which could be causing pain and discomfort. By releasing pressure and muscle tension, a doctor of chiropractic, or chiropractor, can help reduce stress and emotional distress which could be causing the individual’s anxiety, irrational fears, depression and PTSD. If further help is required, the chiropractor can recommend patients to the best healthcare specialist to help them with their symptoms. The purpose of the following article is to demonstrate the prevalence of PTSD on individuals involved in a traffic collision as well as to show how mindfulness interventions can ultimately help improve as well as manage the stress symptoms people may experience after a car crash.
Prediction of Post Traumatic Stress Disorder by Immediate Reactions to Trauma: a Prospective Study in Road Traffic Accident Victims
Abstract
Road traffic accidents often cause serious physical and psychological sequelae. Specialists of various medical faculties are involved in the treatment of accident victims. Little is known about the factors which might predict psychiatric disorders, e.g. Posttraumatic Stress Disorder (PTSD) after accidents and how psychological problems influence physical treatment. In a prospective study 179 unselected, consecutively admitted road traffic accident victims were assessed a few days after the accident for psychiatric diagnoses, severity of injury and psychopathology. All were inpatients and had to be treated for bone fractures. At 6-months follow-up assessment 152 (85%) of the patients were interviewed again. Of the patients, 18.4% fulfilled the criteria for Posttraumatic Stress Disorder (DSM-III-R) within 6 months after the accident. Patients who developed PTSD were injured more severely and showed more symptoms of anxiety, depression and PTSD a few days after the accident than patients with no psychiatric diagnosis. Patients with PTSD stayed significantly longer in the hospital than the other patients. Multiple regression analysis revealed that the length of hospitalization was due mainly to a diversity of factors such as severity of injury, severity of accident, premorbid personality and psychopathology. Posttraumatic stress disorder is common after road traffic accidents. Patients with PTSD at follow-up can be identified by findings from early assessment. Untreated psychological sequelae such as PTSD cause longer hospitalization and therefore more costs than in non-PTSD patients.
Trauma-Focused Cognitive Behavior Therapy and Exercise for Chronic Whiplash: Protocol of a Randomized Controlled Trial
Abstract
Introduction:�As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability.
Aims:�The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression.
Participants and Setting:�A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark.
Intervention:�Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period.
Outcome Measures:�The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes.
Analysis:�All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index.
Discussion:�This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.
Introduction
Persistent pain and disability following whiplash injury as a consequence of a road traffic crash (RTC) is common and incurs substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition [1-3]. Less recognised are the mental health issues that accompany this condition. The prevalence of psychiatric disorders has been shown to be 25% for PTSD, 31% for Major Depressive Episode and 20% for Generalised Anxiety Disorder [4-6]. Whiplash injury accounts for the vast majority of any submitted claims as well as the greatest incurred costs in Queensland compulsory third party scheme [7]. In Australia, Whiplash injuries comprise approximately 75% of all survivable RTC injuries [8] with total costs of more than $950 M per annum [9], exceeding costs for both spinal cord and traumatic brain injury [7]. In Denmark, whiplash costs an estimated 300 million USD per annum if loss of work is included [10].
Neck pain is the cardinal symptom of individuals following whiplash injury. It is now generally accepted that there is an initial peripheral injury of some kind to the neck [11] although the specific injured structure in individual patients is difficult to clinically identify with current imaging techniques. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is not clear but likely results from complex interactions between structural injury, physical impairments, psychological and psychosocial factors [12]. However it is clear that chronic WAD is a heterogeneous and complex condition involving physical impairments such as movement loss, disturbed movement patterns and sensory disturbances [13] as well as pain related psychological responses such as catastrophizing [14, 15], kinesiophobia [16], activity avoidance and poor self-efficacy for pain control [17]. In addition recent studies have shown that posttraumatic stress symptoms or event related distress is common [18-20]. Thus it would seem logical that interventions targeting both the physical and psychological manifestations of the whiplash condition would be of benefit.
In contrast to many common musculoskeletal pain conditions (e.g. low back pain, non-specific neck pain) whiplash related neck pain usually occurs following a traumatic event, namely a motor vehicle crash. Psychological responses related to the traumatic event itself, posttraumatic stress symptoms, are emerging as an important additional psychological factor in the whiplash condition. Recent data indicates that post-traumatic stress symptoms are prevalent in individuals who have sustained whiplash injuries following motor vehicle accidents [18, 20, 21]. The early presence of posttraumatic stress symptoms have been shown to be associated with poor functional recovery from the injury [13, 18]. Recent data from our laboratory have shown that following whiplash injury 17% of individuals will follow a trajectory of initial moderate/severe posttraumatic stress symptoms that persist for at least 12 months and 43% will follow a trajectory of moderate initial symptoms that decrease but remain at mild to moderate (sub-clinical) levels for at least 12 months (the duration of the study) [4]. See Figure 1. These figures are significant as they are similar to the prevalence of PTSD in individuals admitted to hospital following �more severe� motor vehicle injuries [22].
Figure 1: Data from 155 whiplash injured participants measured at 1, 3, 6 & 12 months post-accident. The Posttraumatic Stress Diagnostic Scale (PDS) was measured at each time point. Group based trajectory modelling identified 3 distinct clinical pathways (trajectories). 1. Chronic moderate/severe (17%) 2. Recovering: initial moderate levels of posttraumatic stress decreasing to mild/ moderate levels. 3. Resilient: negligible symptoms throughout2. PDS symptom score Cut-offs: 1�10 mild, 11�20 moderate, 21�35.
Although chronic WAD is a considerable health problem the number of published randomized controlled trials (RCTs) is very limited [23]. A recent systematic review concluded that there is evidence to suggest that exercise programs are modestly effective in relieving whiplash-related pain, at least over the short term [23]. For example, Stewart et al [24] showed only a 2 point (on a 10 point scale) decrease in pain levels immediately after a 6 week functional exercise management intervention that adhered to pain-related CBT principals but with no significant sustained effects at more long term follow-ups of 6 and 12 months. In a preliminary RCT conducted in our laboratory (published in 2007), a more neck specific exercise approach also delivered only modest effects, in that pain and disability scores decreased by just clinically relevant amounts (8�14% on the Neck disability Index) when compared to a single advice session [25].
The systematic review also concluded that there is conflicting evidence regarding the effectiveness of psychological interventions either delivered alone or in combination with physiotherapy [23]. The studies included in the review were of variable quality and mostly utilized CBT in some format to address pain related cognitions and distress [26, 27]. No study specifically targeted PTSD symptoms.
Thus the seemingly logical proposal of interventions to target the physical and pain�related psychological factors of chronic WAD is not working as well as would be anticipated. This expectation is based on more favourable outcomes with such approaches for other musculoskeletal pain conditions such as low back [28].
In an endeavour to understand why exercise rehabilitation approaches are not very effective for chronic WAD, we undertook a NHMRC (570884) funded randomized controlled trial that included effect modifiers of PTSD symptoms and sensory disturbances. In this larger (n=186) multicentre trial, preliminary analysis indicate that only 30% of patients with chronic WAD and a PTSD diagnosis had a clinically relevant change in Neck Disability Index scores (>10% change) compared to 70% of WAD patients without PTSD following an exercise rehabilitation program. All included participants reported moderate or greater levels of pain and disability indicating that the co-morbid presence of PTSD prevents a good response to physical rehabilitation. We could find no modifying effect of any sensory changes. The results of this study lead us to propose that first treating PTSD and then instituting physical rehabilitation will be a more effective intervention to improve health outcomes for chronic WAD.
Trauma-focused CBT is a highly effective treatment for PTSD symptoms [29] and the Australian Guidelines for Treatment of Acute Stress Disorder and PTSD recommend that individually delivered trauma-focused CBT should be provided to people with these conditions [30]. There is data available to indicate that trauma-focused CBT may potentially have an effect not only on PTSD symptoms but also on pain and disability. The results of a recent empirical examination explored directional relationships between PTSD and chronic pain in 323 survivors of accidents [31]. The results indicated a mutual maintenance of pain intensity and posttraumatic stress symptoms at 5 days post injury but by 6 months post injury (chronic stage), PTSD symptoms impacted significantly on pain but not vice versa. Whilst this study did not specifically focus on whiplash injury, it provides indication that addressing PTSD symptoms in the chronic stage of WAD may allow for a decrease in levels of pain thus facilitating the potential effects of more pain/disability focused approaches to management such as exercise and pain-focused CBT.
Based on our findings of the co-occurrence of PTSD and WAD, we conducted a small pilot study with the aim being to test the effects of trauma-focused CBT on psychological factors, pain and disability in individuals with chronic WAD [32]. Twenty-six participants with chronic WAD and a diagnosis of PTSD were randomly assigned to treatment (n = 13) or no-Intervention (n = 13) control. The treatment group underwent 10 weekly sessions of trauma-focused CBT for PTSD. Assessments of PTSD diagnosis, psychological symptoms, disability, and pain symptoms were made at baseline and post-assessment (10-12 weeks). Following the treatment intervention, there was not only a significant reduction in psychological symptoms (PTSD symptom severity; numbers meeting the diagnostic criteria for PTSD; depression, anxiety and stress scores) but also a significant decrease in pain and disability and improvements in physical function, bodily pain and role physical items of the SF36 (Table 1).
Table 1. Results of pilot randomised control trial
Trauma-focused CBT
No-intervention Control
Neck Disability Index (0-100)*
Baseline
43.7 (15)
42.8 (14.3)
Post intervention
38.7 (12.6)
43.9 (12.9)
SF-36 Physical Function �
Baseline
55.8 (25.9)
55.4 (28.2)
Post intervention
61.5 (20.1)
51.1 (26.3)
SF -36 Bodily Pain �
Baseline
31.2 (17.2)
22.6 (15.5)
Post intervention
41.8 (18)
28.2 (15.8)
Posttraumatic Stress Disorder Diagnosis (SCID-IV)
Baseline
N= 13 (100%)
N= 13 (100%)
Post intervention
N= 5 (39.5%)
N= 12 (92.3%)
* higher score=worse; �higher scores=better
The results of this study indicate that trauma-focused CBT provided to individuals with chronic WAD has positive effects, not only on psychological status but also on pain and disability the cardinal symptoms of this condition. Whilst the mean change of 5% was marginal in terms of a clinical relevance [33], the effect size for change of the NDI was moderate (d=0.4) and shows promise for a greater effect in a larger sample size [34]. Nevertheless our pilot trial findings suggest that trauma-focused CBT alone will not be enough for successful management of chronic WAD and for this reason our proposed trial will combine this approach with exercise. These findings are potentially ground breaking in the area of whiplash management and it is imperative that they are now tested in a full randomised controlled design.
In summary, we have already shown that individuals with chronic WAD and moderate PTSD symptoms do not respond as well to a physical rehabilitation based intervention as those without PTSD symptoms [25]. Our recent pilot study indicates that trauma-focused CBT has a beneficial effect on both psychological status and pain and disability. We propose that by pre-treating the PTSD, PTSD symptoms and pain related disability will decrease allowing the exercise intervention to be more effective than has been seen to date [24, 25]. Therefore our proposed research will address this identified gap in knowledge by being the first to evaluate the efficacy of a combined trauma-focused CBT intervention followed by exercise for chronic WAD.
The primary aim of this project is to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease pain and disability of individuals with chronic whiplash and PTSD. The secondary aims are to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease posttraumatic stress symptoms, anxiety and depression, and to investigate the effectiveness of trauma-focused CBT alone on posttraumatic stress symptoms and pain/disability.
This trial is expected to commence in June 2015 and completed by December 2018.
Design
This study will be a randomised controlled multi-centre trial evaluating 10 weeks of trauma-focused CBT compared with 10 weeks of supported therapy, each followed by a 6 week exercise program. Outcomes will be measured at 10 weeks, 16 weeks, 6 and 12 months post randomisation. A total of 108 people with chronic whiplash disorder (>3 months, <5 years duration) and PTSD (DSM-5 diagnosed with CAPS) will be enrolled in the study. The assessors measuring outcomes will be blinded to the assigned treatment group allocation. The protocol conforms to CONSORT guidelines.
Methods
Participants
A total of 108 participants with chronic whiplash associated disorder (WAD) grade II (symptom duration >3 months and <5 years) and PTSD will be recruited from Southeast Queensland and Zealand, Denmark. Participants will be recruited via:
Advertisements (the Danish national health register, newspaper, newsletter and internet): potential participants will be invited to make contact with project staff.
Physiotherapy and General Medical Practices: the study will be promoted in physiotherapy and medical clinics where project staff already have a relationship. Patients deemed to be appropriate for inclusion will be given an information sheet about the project and invited to contact project staff directly.
There is a two-step process to determining inclusion to this study: initial online/telephone interview followed by a screening clinical examination. The initial interview will identify duration of whiplash injury (inclusion criteria) and moderate pain based on NDI scores, and potential exclusion criteria. Likelihood of PTSD will be based on conservative PCL-5 scores, requiring at least one moderate score per symptom and a minimum score of 30 overall. A description of the project will be provided to all volunteers at the point of initial contact. Volunteers deemed likely to be eligible will be invited to attend a screening clinical examination. If more than four weeks passes between the phone interview and clinical screening than the NDI and PCL-5 measures are to be re-administered.
Prior to undertaking the screening clinical examination, volunteers will be provided with participant information and asked to complete informed consent documentation. During the screening examination, participants who have significant co-morbidity such as serious spinal pathology will be identified and excluded from participation. To screen for serious pathology, a diagnostic triage will be conducted following the Motor Accident Authority of NSW Whiplash Guidelines [35]. The screening examination will also include a clinical interview by a research assistant who will administer the Clinician Administered PTSD scale 5 (CAPS 5) to determine the presence and severity of PTSD [36]. The research assistant will also confirm the absence of exclusion criteria such as past history or current presentation of psychosis, bipolar disorder, organic brain disorder and severe depression substance abuse. If participants report a diagnosis of an exclusion criteria the relevant section of SCID-I will be utilised to clarify diagnosis.
During the initial screen or during treatment, if a participant is identified as being at high risk of self-harm or suicide, they will be referred to appropriate care in accordance with the professional standards of psychologists. Participants who meet the inclusion criteria (NDI >30% and PTSD diagnosis) will then be evaluated on all outcome measures for baseline results. It is possible that volunteers invited to attend the screening clinical examination will not meet the inclusion criteria (NDI >30% and PTSD diagnosis) and will therefore be excluded from further participation. Volunteers will be informed of this possibility during the telephone interview and also during the informed consent process. The Interview will be recorded and a random selection will be assessed for consistency
Inclusion Criteria
Chronic WAD Grade II (no neurological deficit or fracture) [37] of at least 3 months duration but less than 5 years duration
At least moderate pain and disability (>30% on the NDI)
A diagnosis of PTSD (DSM-5, APA, 2013) using the CAPS 5
Aged between 18 and 70 years old
Proficient in written English or Danish (depending on country of participation)
Exclusion Criteria
Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine)
Confirmed fracture or dislocation at the time of injury (WAD Grade IV)
Nerve root compromise (at least 2 of the following signs: weakness/reflex changes/sensory loss associated with the same spinal nerve)
Spinal surgery in the last 12 months
A history or current presentation of psychosis, bipolar disorder, organic brain disorder or severe depression.
Sample Size
We are interested in detecting a clinically important difference between the two interventions, given that baseline values for each group are statistically equivalent as a result of the randomisation. Based on a two-sided t-test a sample of 86 (43 per group) will provide 80% power to detect a significant difference at alpha 0.05 between the group means of 10 points on the 100 point NDI (assuming a SD of 16, based on our pilot data and data from recent trials ). Effects smaller than this are unlikely to be considered clinically worthwhile. Allowing for a 20% loss to follow up by 12 months, we would require 54 participants per treatment group.
Intervention
Randomisation
Participants will be randomly allocated to treatment group. The randomisation schedule will be generated by the study biostatistician. Randomisation will be by random permuted blocks of 4 to 8. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation. Group allocation will be performed immediately following completion of baseline measures by an independent (non-blinded) research assistant . This same research assistant will arrange all appointment times with the treating practitioners and the blinded assessor for all outcome measures. Participants will be instructed not to reveal details about their treatment to the examiner in order to assist with blinding. Patients will be scheduled to receive their first treatment within one week of randomisation.
Intervention group – Trauma-focused Cognitive-behavioural therapy (CBT)
A psychological intervention that targets PTSD symptoms will consist of 10 weekly 60-90 minute sessions of individually delivered trauma-focused CBT based on the Australian Guidelines for the treatment of Adults with Acute Stress Disorder and PTSD [38] (see Table 2). Session one will focus on providing psycho-education regarding the common symptoms of PTSD, maintaining factors and providing a rationale for various treatment components. Sessions two and three will continue to develop patient�s knowledge of PTSD symptoms and teach anxiety management strategies including deep breathing and progressive muscle relaxation. Cognitive restructuring which involves challenging unhelpful and irrational thoughts and beliefs will commence in session three and continue throughout treatment. Participants will start prolonged exposure in session four which will be paired with relaxation and cognitive challenging. Session six will introduce graded in-vivo exposure. Relapse prevention will also be included in the final two sessions [12]. Participants will be asked to complete a home practice over the course of their sessions which will be recorded and brought to the next session. Treatment will be delivered by registered psychologists with postgraduate clinical training and experience delivering trauma-focused CBT interventions.
Table 2. Overview of CBT program
Session
Overview
1
Introduction and rationale
2
Relaxation training
3
Relaxation training and cognitive challenging
4 and 5
Cognitive challenging and prolonged exposure
6
Prolonged exposure and in vivo exposure
7 and 8
Prolonged exposure and in-vivo exposure
9
Relapse prevention
10
Relapse prevention and end of treatment
Control group – Supportive Therapy
The first session will involve education about trauma and an explanation of the nature of supportive therapy. The following sessions will include discussions of current problems and general problem-solving skills. Home practice will involve diary keeping of current problems and mood states. Supportive therapy will specifically avoid exposure, cognitive restructuring or anxiety management techniques. If the results of the trial are favourable and participants randomised to this intervention still have a PTSD diagnosis at the 12 month follow-up, they will be offered a referral to a clinical psychologist.
Exercise Program
Following the 10 week psychological therapy sessions (intervention or control), All participants will participate in the same exercise program. The 6-week exercise program will be carried out under supervision from a physiotherapist (2 sessions in each of the first four weeks; and 1 session in week 5 and week 6) and will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as proprioceptive and co-ordination exercises (see Table 3). The exercises will be tailored by the physiotherapist for each individual participant.
The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments that are identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program has been described in detail [15] and focuses on activating and improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system, including balance exercises, head relocation exercises and exercises for eye movement control.
Participants will also perform the exercises at home, once a day. A log book will be completed by participants to record compliance with the exercises. At the same time, the physiotherapist will guide the subject�s return to normal activities.
Physiotherapists will adhere to cognitive-behavioural principles during training and supervision of all exercises [26]. The cognitive behavioural therapy principles include the encouragement of skill acquisition by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of progress. Self-reliance will be fostered by encouraging subjects to engage in problem-solving to deal with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and monitored using a diary. Written and illustrated exercise instructions will be provided.
Table 3. Overview of the exercise program
Week
Sessions per week
Components
1
2
������� Baseline & follow-up assessments to guide initial prescription & progression of program
������� Exercise to improve cervical and scapular muscle control, kinaesthesia & balance
������� Education and advice
������� Daily home program including exercise & graded increase of physical activities
������� CBT principles such as goal setting, reinforcement used by physiotherapists
������� Discharge session to reinforce progress and plan for continued activity
2
2
3
2
4
2
5
1
6
1
Outcome Measures
At the baseline assessment, personal characteristics such as age, gender, level of education, compensation status, accident date and information about symptoms of whiplash will be collected. The following outcome measures will be assessed by a blind assessor at baseline, 10 weeks, 16 weeks, 6 months and 12 months post randomisation.
The Neck Disability Index (NDI) will be the primary outcome measure [21]. The NDI is a valid measure and reliable measure of neck pain related disability [21] and is recommended for use by the Bone and Joint Decade Neck Pain Task Force [7] and at the recent International Whiplash Summit [11, 16].
Secondary outcome measures include:
Average pain intensity over last week (0-10 scale) [39]
Average pain intensity over last 24 hours (0-10 scale) [39]
Patient�s global impression of recovery (-5 to +5 scale) [39]
Patient-generated measure of disability (Patient-Specific Functional Scale) [44]
Physical measures (cervical range of movement, pressure pain threshold, cold pain threshold)
Pain Catastrophizing Scale (PCS) [45]
Pain Self Efficacy Questionnaire (PSEQ) [46]
Tampa Scale of Kinesiophobia (TSK) [47]
Expectations of a beneficial treatment effect will be measured with the Credibility Expectancy Questionnaire (CEQ) [48] at the first and last week of each treatment. Working alliance as reported by the client and the therapist (psych or physio) will also be measured at the first and last week of each treatment using the Working Alliance Inventory (WAI) [49].
Monitoring of Treatment Sites
Treatment sites will be located in areas easily accessible by public transport. Attempts will be made to have both the psychology and exercise sessions held at the same site. Prior to commencement of the trial, psychologists and physiotherapists at each treatment site will be provided with the appropriate therapist protocol. Psychologists will be trained to implement the CBT program and the supported therapy by senior investigators at a one day workshops. Physiotherapists will be trained by senior investigators to implement the exercise program at a one day workshop.
Prior to starting the trial, the different treatment provider sites and therapists will be provided with a copy of the trial and treatment protocols. Both psychological therapies will be conducted according to a procedural manual. Therapists will be required to record each session as well as complete a checklist of adherence to the protocol. A random sample of these recordings and checklists will be evaluated and ongoing supervision provided by a psychologist on the research team. Physiotherapy exercises will be based on a previous exercise trial for chronic WAD [25]. An audit of the physiotherapy sessions will be conducted twice during the intervention by a senior investigator expert in this area. A handover will occur between psychologist and physiotherapist to maintain continuity of care.
Adverse Events
Apart from the usual ethics committee based provisions for reporting of adverse effects, practitioners will be requested to report any adverse event to the Chief Investigators. Also at the 16 week follow-up, information about adverse effects of treatment will be sought from all subjects using open-ended questioning. At 6 and 12 months follow-up, data relating to the number of recurrences of neck pain, and the number of health care contacts will also be collected.
Statistical Analysis
The study biostatistician will analyse the data in a blinded manner. All analyses will be conducted on an intention to treat basis. The primary and secondary outcomes measured at 10 weeks, 16 weeks, 6 months, and 12 months will be analysed using linear mixed and logistic regression models that will include their respective baseline scores as a covariate, subjects as a random effect and treatment conditions as fixed factors. Diagnostics will be used to examine assumptions, including homogeneity of variances. Effect sizes will be calculated for all measures with an effect size of 0.2 considered small, 0.5 medium and 0.8 large. Alpha will be set at 0.05. Any effect of site (Qld or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term to the mixed models analyses. Effect modification will only be assessed for the primary outcome of NDI.
Funding
The trial is funded by a NHMRC Project grant 1059310.
The Council of the Danish Victims Fund Project grant 14-910-00013
Potential Significance
This project addresses a problem of major importance to human health. Whiplash is an enormous health burden for both Australia and all countries where there are motor vehicles. Current conservative approaches to the management of chronic WAD have been shown to be only marginally effective. One reason for this may be due to the lack of attention of current practice to the psychological status of whiplash injured patients. This study will provide a definitive evaluation of the effects of adding trauma-focused CBT to exercise for individuals with chronic WAD and PTSD.
This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability. Any intervention that may improve health outcomes for individuals with chronic whiplash will have far reaching effects in both Australia and internationally. Our study will also have implications for both health and insurance policy makers in their decision making regarding treatment options and funding. A search of the WHO International Clinical Trials Registry Platform Search Portal on 2/3/13 revealed no planned or completed trial that would duplicate our work.
Conflict of Interest Declaration
The authors declare no conflict of interest.
Role of Psychosocial Stress in Recovery from Common Whiplash
Abstract
It is widely accepted that psychosocial factors are related to illness behaviour and there is some evidence that they may influence the rate of recovery from post-traumatic disorders. The abilities of psychosocial stress, somatic symptoms, and subjectively assessed cognitive impairment to predict delayed recovery from common whiplash were investigated in a follow-up study. 78 consecutive patients referred 7.2 (SD 4.5) days after they had sustained common whiplash in car accidents were assessed for psychosocial stress, negative affectivity, personality traits, somatic complaints, and cognitive impairment by semistructured interview and by several standardised tests. On examination 6 months later 57 patients were fully recovered and 21 had persisting symptoms. The groups’ scores for the independent variables assessed at the baseline examination were compared. Stepwise regression analysis showed that psychosocial factors, negative affectivity, and personality traits were not significant in predicting the outcome. However, initial neck pain intensity, injury-related cognitive impairment, and age were significant factors predicting illness behaviour. This study, which was based on a random sample and which considered many other possible predictive factors as well as psychosocial status, does not support previous findings that psychosocial factors predict illness behaviour in post-trauma patients.
Dr. Alex Jimenez’s Insight
Being involved in an automobile accident can be a traumatic experience for anyone. From physical injuries and financial problems, to emotional distress, an auto accident can place a heavy burden on those individuals who’ve experienced it, especially if the auto accident injuries begin to take a toll on the mind. Many patients visit my chiropractic office with anxiety, irrational fears, depression and PTSD after being involved in an automobile accident. Learning to trust again to receive chiropractic care can be challenging, but through careful and effective spinal adjustments and manual manipulations, our staff can provide patients with the sense of safety they need to continue treatment and achieve overall health and wellness.
In conclusion,�automobile accidents can cause a variety of physical injuries and conditions, such as whiplash, back pain and headaches, as well as financial issues, however, auto accident injuries and complications can also lead to emotional distress. According to evidence-based research studies, like the one above, emotional distress has been connected to chronic pain symptoms. Fortunately, researchers have conducted numerous research studies to demonstrate how mindfulness interventions, like chiropractic care, can help reduce emotional distress and improve painful symptoms. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Back Pain
According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.
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Chiropractic care for spinal disc problems is steadily increasing in popularity. As more and more research proves the effectiveness for chiropractic for these types of problems, doctors and therapists are incorporating it into treatment plans for their patients.
Spinal disc problems can be debilitating, causing significant pain and severely limiting mobility. Degenerative disc disease is one of the most common spinal problems, causing back pain that, like other spinal conditions, can extend into the hip and leg or even the arm and hand.
It is caused by degeneration or thinning of the spinal joints or discs which can disrupt the mechanics of the spine and contribute to bulging discs that press on spinal nerves. Traditional treatment of this condition usually consists of strong pain medication and sometimes surgery.
Patients who are dealing with pain from discs that are bulging or ruptured as well as herniated, or slipped discs, do respond well to chiropractic care. Where surgery has long been a primary medical answer to pain relief for these spinal conditions, chiropractic treatments offer a nonsurgical alternative that has been shown to be very effective.
Most spinal or disc problems are marked by a specific set of symptoms including neck and back pain, stiffness, arm pain, leg pain, and tenderness in the spinal muscles or the spine itself. Other more serious symptoms can present at the onset of the condition or over a period of time. These symptoms indicate a dangerous problem that could even be life threatening; they include:
Back pain accompanied by fever
Loss of control of bladder or bowel
Severe weakness that inhibits the ability to use arms, legs, walk, etc.
Loss of sensation in both arms and/or both buttocks
Inability to defecate or urinate
More serious or life threatening symptoms may require medical intervention, but most spinal conditions can be helped or even corrected with chiropractic care.
Through the careful, precise manipulation of the spine, a chiropractor can make adjustments to the body that help relieve the pain and pressure. This treatment can halt the debilitating progression of certain spinal problems while relieving pain and increasing mobility.
Spinal problems are usually diagnosed by a combination of complete physical examination and a thorough patient history. During the examination the patient�s musculoskeletal and nervous systems are carefully assessed. A doctor of chiropractic will examine the patient by moving the patient into different positions using their legs, arms, and back while applying pressure to the joints. Other diagnostic tools include x-rays and magnetic resonance imaging (MRI).
The preferable course of treatment for spinal problems is more conservative in nature. The earlier the problem can be diagnosed and treatment can begin, the better. There are several different treatments that a doctor of chiropractic may do to control and treat the pain. Modalities such as heat and ice applied to the affected area have been proven effective in controlling injury related pain in the lower back.
Movement is also crucial to healing and the sooner the patient gets back on their feet, the better. For most injuries or back problems, those problems are exacerbated when the patient stays in bed or coddles their back instead of walking and moving. It can result in long term back problems.
Spinal manipulation by a doctor of chiropractic has been proven to be an effective, safe treatment for disc problems and associated pain. In some cases therapeutic exercise may be added to the treatment and this too has been shown to be very effective.
In most cases, chiropractic care is sufficient and surgery of the spine or injections are unnecessary to manage the problems. In fact, these more invasive therapies often create more problems than they cure. Chiropractic care should be the first course of action for spine related pain, injury, or problems. So if you or a loved one are suffering from spinal disc problems, make sure you give us a call. We�re here to help!
Spinal Disc Problems: Chiropractic Treatment Can Help
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