Randomized Controlled Trial

Back Clinic Randomized Controlled Trial Chiropractic and Functional Medicine Team. A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions. Using the chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly.

At the time of the trial, it is not known which treatment is best. A Randomized Controlled Trial or (RCT) design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference from the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.

Advantages

Easier to blind/mask than from observational studies
Good randomization washes out any population bias
Populations of participating individuals are clearly identified
Results can be analyzed with well known statistical tools

Disadvantages

Does not reveal causation
Expensive in time and money
Loss to follow-up attributed to treatment
Volunteer biases: the population that participates may not be representative of the whole

For answers to any questions you may have please call Dr. Jimenez at 915-850-0900

Work Injury Health Guidelines for Low Back Pain in El Paso, TX

by spinedoctors | Back Pain, Chiropractic, Chronic Pain, Randomized Controlled Trial

Low back pain represents one of the most common complaints in healthcare settings. While various injuries and conditions associated with the musculoskeletal and nervous system can cause low back pain, many healthcare professionals believe that work injury may have a prevalent connection to low back pain. For instance, improper posture and repetitive movements may often cause work-related injuries. In other cases, environmental accidents at work may cause work injuries. In any case, diagnosing the source of a patient’s low back pain to correctly determine which would be the best treatment method to restore the individual’s original health and wellness is generally challenging.

First and foremost, getting the right doctors for your specific source of low back pain is essential for finding relief from your symptoms. Many healthcare professionals are qualified and experienced in treating work-related low back pain, including doctors of chiropractic or chiropractors. As a result, several work injury treatment guidelines have been established to manage low back pain in healthcare settings. Chiropractic care focuses on diagnosing, treating, and preventing various injuries and conditions, such as LBP, associated with the musculoskeletal and nervous system. By carefully correcting the misalignment of the spine, chiropractic care can help improve symptoms of low back pain, among other symptoms. The purpose of the following article is to discuss occupational health guidelines for the management of low back pain.

Occupational Health Guidelines for the Management of Low Back Pain: an International Comparison

Name: El Paso Back Clinic | Spine Specialists - El Paso, TX
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Abstract

Background: The enormous socioeconomic burden of low back pain emphasizes the need to manage this problem, especially in an occupational context effectively. To address this, occupational guidelines have been issued in various countries.
Aims: To compare available international guidelines for managing low back pain in an occupational health care setting.
Methods: The guidelines were compared regarding generally accepted quality criteria using the AGREE instrument and also summarised regarding the guideline committee, the presentation, the target group, and assessment and management recommendations (that is, advice, return to work strategy, and treatment).
Results and Conclusions: The results show that the guidelines variously met the quality criteria. Common flaws concerned the absence of proper external reviewing in the development process, lack of attention to organizational barriers and cost implications, and lack of information on the extent to which editors and developers were independent. There was general agreement on numerous issues fundamental to occupational health management of back pain. The assessment recommendations included diagnostic triage, screening for red flags and neurological problems, and identifying potential psychosocial and workplace barriers to recovery. The guidelines also agreed on advice that low back pain is a self-limiting condition and that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.

Dr. Alex Jimenez’s Insight

Low back pain is one of the most prevalent health issues treated in chiropractic offices. Although the following article describes low back pain as a self limiting condition, the cause of an individual’s LBP can also trigger debilitating and severe pain and discomfort of left untreated. It’s important for an individual with symptoms of low back pain to seek proper treatment with a chiropractor to properly diagnose and treat their health issues as well as prevent them from returning in the future. Patients who experience low back pain for more than 3 months are less than 3 percent likely to return to work. Chiropractic care is a safe and effective alternative treatment option which can help restore the original function of the spine. Furthermore, a doctor of chiropractic, or chiropractor, can provide lifestyle modifications, such as nutritional and fitness advice, to speed up the patient’s recovery process. Healing through movement is essential for LBP recovery.

Low back pain (LBP) is one of the industrial countries’ most common health problems. Despite its benign nature and sound course, LBP is commonly associated with incapacity, productivity loss due to sick leave, and high societal costs.[1]

Because of that impact, there is an obvious need for effective management strategies based on scientific evidence derived from studies of sound methodological quality. Usually, these are randomized controlled trials (RCTs) on the effectiveness of therapeutic interventions, diagnostic studies, or prospective observational studies on risk factors or side effects. The scientific evidence, summarised in systematic reviews and meta-analyses, provides a solid basis for guidelines on managing LBP. In a previous paper, Koes et al. compared various existing clinical guidelines for managing LBP targeted at primary healthcare professionals, showing a considerable commonality.[2]

The problems in occupational health care are different. Management focuses mainly on counseling the worker with LBP and addressing the issues of assisting them to continue working or return to work (RTW) after sick listing. However, LBP is also an important issue in occupational health care because of the associated incapacity for work, productivity loss, and sick leave. Several guidelines, or sections of guidelines, have now been published dealing with the specific issues of management in an occupational health care setting. Since the evidence is international, it would be expected that the recommendations of different occupational guidelines for LBP would be more or less similar. However, it is not clear whether the guidelines meet currently accepted quality criteria.

This paper critically appraises available occupational guidelines on managing LBP and compares their assessment and management recommendations.

Main Messages

In various countries, occupational health guidelines are issued to improve the management of low back pain in an occupational context.
Common flaws of these guidelines concern the absence of proper external reviewing in the development process, lack of attention to organizational barriers and cost implications, and lack of information on the independence of editors and developers.
In general, the assessment recommendations in the guidelines consisted of diagnostic triage, screening for red flags and neurological problems, and identifying potential psychosocial and workplace barriers to recovery.
There is general agreement on advice that low back pain is a self-limiting condition and that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.

Methods

Guidelines on the occupational health management of LBP were retrieved from the authors’ personal files. Retrieval was checked by a Medline search using the keywords low back pain, guidelines, and occupational up to October 2001, and personal communication with experts in the field. Policies had to meet the following inclusion criteria:

Guidelines aimed at managing workers with LBP (in occupational health care settings or addressing occupational issues) or separate sections of policies that dealt with these topics.
Guidelines are available in English or Dutch (or translated into these languages).

The exclusion criteria were:

Guidelines on primary prevention (that is, prevention before the onset of the symptoms) of work-related LBP (for example, lifting instructions for workers).
Clinical guidelines for the management of LBP in primary care.[2]

The quality of the included guidelines was appraised using the AGREE instrument, a generic tool designed primarily to help guideline developers and users assess the methodological quality of clinical practice guidelines.[3]

The AGREE instrument provides a framework for assessing the quality on 24 items (table 1), each rated on a four-point scale. The full operationalization is available on www.agreecollaboration.org.

Two reviewers (BS and HH) independently rated the quality of the guidelines and then met to discuss disagreements and to reach a consensus on the ratings. When they could not agree, a third reviewer (MvT) reconciled the remaining differences and decided on the ratings. To facilitate analysis in this review, ratings were transformed into dichotomous variables of whether each quality item was or was not met.

The assessment recommendations were summarised and compared to recommendations on advice, treatment, and return to work strategies. The selected guidelines were further characterized and reached regarding the guideline committee, the presentation of the procedure, the target group, and the extent to which the recommendations were based on available scientific evidence. All of this information was extracted directly from the published guidelines.

Policy Implications

The management of low back pain in occupational health care should follow evidence-based guidelines.
Future occupational guidelines for managing low back pain and updates of those guidelines should consider the criteria for proper development, implementation, and evaluation of approaches as suggested by the AGREE collaboration.

Results

Selection of Studies

Our search found ten guidelines, but four were excluded because they dealt with the management of LBP in primary care,[15] were aimed at the guidance of sick-listed employees in general (not specifically LBP),[16] were intended for the primary prevention of LBP at work,[17] or were not available in English or Dutch.[18] The final selection, therefore, consisted of the following six guidelines, listed by date of issue:

(1) Canada (Quebec). A scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Quebec Canada (1987).[4]

(2) Australia (Victoria). Guidelines for the management of employees with compensable low back pain. Victorian WorkCover Authority, Australia (1996).[5] (This is a revised version of guidelines developed by the South Australian WorkCover Corporation in October 1993.)

(3) the USA. Occupational Medicine Practice Guidelines. American College of Occupational and Environmental Medicine. USA (1997).[6]

(4) New Zealand

(a)Active and working! Managing acute low back pain in the workplace. Accident Compensation Corporation and National Health Committee. New Zealand (2000).[7]

(b)Patient guide to acute low back pain management. Accident Compensation Corporation and National Health Committee. New Zealand (1998).[8]

(c) Assess psychosocial yellow flags in acute low back pain. Accident Compensation Corporation and National Health Committee. New Zealand (1997).[9]

(5) the Netherlands. Dutch guideline for managing occupational physicians of employees with low back pain. Dutch Association of Occupational Medicine (NVAB). Netherlands (1999).[10]

(6) the UK

(a)Occupational health guidelines for managing low back pain at work principal recommendations. Faculty of Occupational Medicine. UK (2000).[11]

(b)Occupational health guidelines for managing low back pain at work leaflet for practitioners. Faculty of Occupational Medicine. UK (2000).[12]

(c)Occupational health guidelines for managing low back pain at work evidence review. Faculty of Occupational Medicine. UK (2000).[13]

(d)The Back Book, The Stationery Office. UK (1996).[14]

Two guidelines (4 and 6) could not be evaluated independently from additional documents to which they refer (4bc, 6bd), so these documents were also included in the review.

Appraisal of the Quality of the Guidelines

Initially, there was an agreement between the two reviewers regarding 106 (77%) of the 138 item ratings. After two meetings, the consensus was reached for all but four items, which required adjudication by the third reviewer. Table 1 presents the final ratings.

All included guidelines presented the different options for managing LBP in occupational health. In five of the six policies, the overall objectives of the procedure were explicitly described,[46, 1014] the target users of the system were clearly defined,[514] easily identifiable key recommendations were included,[4, 614] or critical review criteria were presented for monitoring and audit purposes.[49, 1114]

The results of the AGREE appraisal showed that none of the guidelines paid sufficient attention to potential organizational barriers and cost implications in implementing the recommendations. It was also unclear for all included guidelines whether or not they were editorially independent of the funding body and whether or not there were conflicts of interest for the members of the guideline development committees. Furthermore, it was unclear for all guidelines whether experts had externally reviewed the policies before publication. Only the UK guideline clearly described the method used to formulate the recommendations and provided for updating the approach.[11]

Table 1 Ratings of the Occupational Health Guidelines

Development of the Guidelines

Table 2 presents background information on the development process of the guidelines.

The target users for the guidelines were physicians and other healthcare providers in the field of occupational healthcare. Several policies were also directed at informing employers, workers [68, 11, 14], or members of organizations interested in occupational health.[4] The Dutch guideline was only targeted at the occupational health physician.[10]

The guideline committees responsible for developing the guidelines were generally multidisciplinary, including disciplines like epidemiology, ergonomics, physiotherapy, general practice, occupational medicine, occupational therapy, orthopedics, and representatives of employers’ associations and trade unions. Chiropractic and osteopathic representatives were in the guideline committee of the New Zealand guidelines.[79] The Quebec task force (Canada) also included representatives of rehabilitation medicine, rheumatology, health economics, law, neurosurgery, biomechanical engineering, and library sciences. In contrast, the guideline committee of the Dutch guideline consisted only of occupational physicians.[10]

The guidelines were issued as a separate document,[4, 5, 10] as a chapter in a textbook,[6] or as several interrelated documents.[79, 1114]

The UK,[13] the USA,[6] and Canadian[4] guidelines provided information on the search strategy applied to the identification of relevant literature and the weighing of the evidence. On the other hand, the Dutch[10] and the Australian[5] guidelines supported their recommendations only by references. The New Zealand guidelines showed no direct links between suggestions and concerns [79]. The reader was referred to other literature for background information.

Table 2 Background Information of the Guidelines

Table 3 Occupational Guidelines Recommendations

Table 4 Occupational Guidelines Recommendations

Patient Population and Diagnostic Recommendations

Although all guidelines focused on workers with LBP, it was often unclear whether they dealt with acute or chronic LBP or both. Acute and chronic LBP were often not defined, and cut-off points were given (for example, <3 months). It was usually unclear whether these referred to the onset of symptoms or absence from work. However, the Canadian guideline introduced a classification system (acute/subacute/ chronic) based on the distribution of claims of spinal disorders by time since absence from work.[4]

All guidelines distinguished specific and non-specific LBP. Specific LBP concerns the potentially serious red flag conditions like fractures, tumors, or infections, and the Dutch and UK guidelines also distinguish the radicular syndrome or nerve root pain.[1013] All procedures were consistent in their recommendations to take a clinical history and to carry out a physical examination, including neurological screening. In cases of suspected specific pathology (red flags), x-ray examinations were recommended by most guidelines. In addition, New Zealand and the US guideline also recommended an x-ray examination when symptoms did not improve after four weeks.[6, 9] The UK guideline stated that x-ray examinations are not indicated and do not assist occupational health management of the patient with LBP (distinct from any clinical indications).[1113]

Most guidelines considered psychosocial factors as yellow flags as obstacles to recovery that healthcare providers should address. The New Zealand[9] and UK guidelines [11, 12] explicitly listed factors and suggested questions to identify those psychosocial yellow flags.

All guidelines addressed the importance of the clinical history identifying physical and psychosocial workplace factors relevant to LBP, including physical demands of work (manual handling, lifting, bending, twisting, and exposure to whole-body vibration), accidents or injuries, and perceived difficulties in returning to work or relationships at work. The Dutch and the Canadian guidelines contained recommendations to carry out a workplace investigation[10] or an assessment of occupational skills when necessary.[4]

Summary of Recommendations for the Assessment of LBP

Diagnostic triage (non-specific LBP, radicular syndrome, specific LBP).
Exclude red flags and neurological screening.
Identify psychosocial factors and potential obstacles to recovery.
Identify workplace factors (physical and psychosocial) that may be related to the LBP problem and return to work.
X-Ray examinations are restricted to suspected cases of specific pathology.

Recommendations Regarding Information and Advice, Treatment, and Return to Work Strategies

Most guidelines recommended reassuring the employee and providing information about LBP’s self-limiting nature and good prognosis. Encouragement of return to ordinary activity as generally as possible was frequently advised.

In line with the recommendation to return to regular activity, all guidelines also stressed the importance of returning to work as rapidly as possible, even if there is still some LBP and, if necessary, starting with modified duties in more severe cases. Work duties could then be increased gradually (hours and tasks) until total return to work was reached. The US and Dutch guidelines provided detailed time schedules for return to work. The Dutch approach proposed a return to work within two weeks with an adaptation of duties when necessary.[10] The Dutch system also stressed the importance of time-contingent management about a return to work.[10] The US guideline proposed every attempt to maintain the patient at maximal levels of activity, including work activities; targets for disability duration in terms of return to work were given as 02 days with modified duties and 714 days if modified duties are not used/available.[6] In contrast to the others, the Canadian guideline advised return to work only when symptoms and functional restrictions had improved.[4]

The most frequently recommended treatment options in all the included guidelines were: medication for pain relief,[5, 7, 8] gradually progressive exercise programs,[6, 10] and multidisciplinary rehabilitation.[1013] The US guideline recommended referral within two weeks to an exercise program consisting of aerobic exercises, conditioning exercises for trunk muscles, and exercise quota.[6] The Dutch guideline recommended that if there is no progress within two weeks of work absence, workers should be referred to a graded activity program (gradually increasing exercises) and, if there is no improvement by four weeks, to a multidisciplinary rehabilitation program.[10] The UK guideline recommended that workers who have difficulty returning to regular occupational duties by 412 weeks should be referred to an active rehabilitation program. This rehabilitation program should include education, reassurance and advice, a progressive vigorous exercise and fitness program, and pain management according to behavioral principles; it should be embedded in an occupational setting and directed firmly toward a return to work.[11-13] Extensive lists of possible treatment options were presented in the guidelines of Canada and Australia [4, 5], although most of these were not based on scientific evidence.

Summary of Recommendations Regarding Information, Advice, Return to Work Measures, and Treatment in Workers with LBP

Reassure the worker and provide adequate information about LBP’s self-limiting nature and good prognosis.
Advise the worker to continue ordinary activities or to return to regular exercise and work as soon as possible, even if there is still some pain.
Most workers with LBP return to more or less regular duties quite rapidly. Consider temporary adaptations of work duties (hours/tasks) only when necessary.
When a worker fails to return to work within 212 weeks (there is considerable variation in the time scale in different guidelines), refer them to a gradually increasing exercise program, or multidisciplinary rehabilitation (exercises, education, reassurance, and pain management following behavioral principles). These rehabilitation programs
should be embedded in an occupational setting.

Discussion

The management of LBP in an occupational health setting must address the relation between low back complaints and work and develop strategies aimed at a safe return to work. This review compared available occupational health guidelines from various countries. Policies are rarely indexed in Medline, so when searching for guidelines, we had to rely primarily on personal files and personal communication.

Quality Aspects and Development Process of the Guidelines

The assessment by the AGREE instrument[3] showed some differences in the quality of the guidelines reviewed, which may partly reflect the variation in the dates of development and publication of the guidelines. The Canadian guideline, for example, was published in 1987 and the Australian guideline in 1996.[4, 5] The other guidelines were more recent and incorporated a more extensive evidence base and more up to date guideline methodology.

Several common flaws related to the development process of the guidelines were shown by the assessment by the AGREE instrument. Firstly, it is important to make clear whether a guideline is editorially independent from the funding body, and whether there are conflicts of interest for the members of the guideline committee. None of the included guidelines clearly reported these issues. Further, reported external review of the guideline by clinical and methodological experts prior to publication was also lacking in all guidelines included in this review.

Several guidelines provided comprehensive information on the way relevant literature was searched and translated into recommendations.[4, 6, 11, 13] Other guidelines supported their recommendations by references,[5, 7, 9, 10] but this does not permit assessment of the robustness of the guidelines or their recommendations.

Guidelines depend on the scientific evidence, which changes over time, and it is striking that only one guideline provided for future update.[11, 12] Possibly there are updates planned for the other guidelines but they are not explicitly stated (and conversely stating there will be future update does not mean it will actually occur). This lack of reporting may also hold true for other AGREE criteria that we rated negatively. The use of the AGREE framework as a guide for both the development and the reporting of guidelines should help to improve the quality of future guidelines.

Assessment and Management of LBP

The diagnostic procedures recommended in the occupational health guidelines were largely similar to the recommendations of clinical guidelines,[2] and, logically, the main difference was the emphasis on addressing occupational issues. The reported methods for addressing workplace factors in the assessment of LBP of the individual worker concerned the identification of difficult tasks, risk factors, and obstacles for return to work by occupational histories. Obviously, these obstacles for return to work not only concern physical load factors, but also work related psychosocial problems regarding responsibilities, cooperation with co-workers, and the social atmosphere at the workplace.[10] Screening for work related psychosocial yellow flags may help to identify those workers who are at risk for chronic pain and disability.[1113]

A potentially important feature of the guidelines is that they were consistent regarding their recommendations to reassure the employee with LBP, and to encourage and support return to work even with some persisting symptoms. There is general consensus that most workers do not have to wait until they are completely free of pain before returning to work. The lists of treatment options provided by the Canadian and Australian guidelines may reflect the lack of evidence at that time,[4, 5] leaving users of the guidelines to choose for themselves. It is, however, questionable whether such lists really contribute to improved care, and in our view guideline recommendations should be based on sound scientific evidence.

The US, Dutch, and UK occupational guidelines[6, 1013] recommend that active multidisciplinary treatment is the most promising intervention for return to work, and this is supported by strong evidence from RCTs.[19, 20] However, more research is still needed to identify the optimum content and intensity of those treatment packages.[13, 21]

Despite some evidence for a contribution of workplace factors in the aetiology of LBP,[22] systematic approaches for workplace adaptations are lacking, and are not offered as recommendations in the guidelines. Perhaps this represents a lack of confidence in the evidence on the overall impact of workplace factors, a difficulty of translation into practical guidance, or because these issues are confounded with local legislation (which was hinted at in the UK guideline[11]). It may be that the participatory ergonomics intervention, which proposes consultations with the worker, the employer, and an ergonomist, will turn out to be a useful return to work intervention.[23, 24] The potential value of getting all the players onside[25] was stressed in the Dutch and the UK guidelines,[1113] but further evaluation of this approach and its implementation is required.

Development of Future Guidelines in Occupational Health Care

The purpose of this review was to give both an overview and a critical appraisal of occupational guidelines for the management of LBP. The critical appraisal of the guidelines is meant to help direct future development and planned updates of guide- lines. In the still emerging field of guideline methodology we consider all past initiatives as laudable; we recognise the need for clinical guidance, and appreciate that guidelines developers cannot wait for research to provide all the methodology and evidence required. However, there is room for improvement and future guidelines and updates should consider the criteria for proper development, implementation, and evaluation of guidelines as suggested by the AGREE collaboration.

The implementation of the guidelines is beyond the scope of this review, but it was noted that none of the guideline documents specifically described implementation strategies, so it is uncertain to what extent the target groups may have been reached, and what effects that may have had. This may be a fruitful area for further research.

The very existence of these occupational health guidelines shows that existing primary care clinical guidelines for LBP2 are considered inappropriate or insufficient for occupational health care. There is a clear perception internationally that the needs of the worker experiencing back pain are intrinsically linked to a variety of occupational issues not covered by usual primary care guidance and, consequently, practice. What emerges is that, despite the methodological flaws, considerable agreement is evident on a range of fundamental occupational health strategies for managing the worker with back pain, some of which are innovative and challenge previously held views. There is agreement on the fundamental message that prolonged work loss is detrimental, and that early work return should be encouraged and facilitated; there is no need to wait for complete symptom resolution. Although the recommended strategies vary somewhat, there is considerable agreement on the value of positive reassurance and advice, availability of (temporary) modified work, addressing workplace factors (getting all the players onside), and rehabilitation for workers having difficulty returning to work.

Acknowledgements

This study was supported by the Dutch Health Care Insurance Council (CVZ), grant DPZ no. 169/0, Amstelveen, Netherlands. J B Staal is currently working at the Department of Epidemiology, Maastricht University, PO Box 616 6200 MD Maastricht, Netherlands. W van Mechelen is also part of the Research Centre on Physical Activity, Work and Health, Body@work TNO-VUmc.

In conclusion, symptoms of low back pain are one of the most common health issues associated with work injuries. Because of it, several occupational health guidelines have been established for the management of low back pain. Chiropractic care, among other treatment methods, may be utilized in order to help the patient find relief from their LBP. Furthermore, the article above demonstrated the safety and effectiveness of a variety of traditional as well as alternative treatment options in the diagnosis, treatment and prevention of a variety of low back pain cases. However, further research studies are required in order to properly determine the efficiency of each individual treatment method. 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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EXTRA IMPORTANT TOPIC: Migraine Pain Treatment

MORE TOPICS: EXTRA EXTRA: El Paso, Tx | Athletes

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References

1. Van Tulder MW, Koes BW, Bouter LM. A cost-of-illness study of back pain in the Netherlands. Pain 1995;62:233�40.
2. Koes BW, van Tulder MW, Ostelo R, et al. Clinical guidelines for the management of low back pain in primary care: an international
comparison. Spine 2001;26:2504�14.
3. The AGREE Collaboration. Appraisal of Guidelines Research &
Evaluation Instrument, www.agreecollaboration.org.
4. Spitzer WO, Leblanc FE, Dupuis M. Scientific approach to the
assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine 1987;12(suppl 7S):1�59.
5. Victorian WorkCover Authority. Guidelines for the management of employees with compensable low back pain. Melbourne: Victorian WorkCover Authority, 1996.
6. Harris JS. Occupational medicine practice guidelines. Beverly, MA: OEM Press, 1997.
7. Accident Compensation Corporation and National Health Committee. Active and working! Managing acute low back pain in the workplace. Wellington, New Zealand, 2000.
8. Accident Compensation Corporation and National Health Committee, Ministry of Health. Patient guide to acute low back pain management. Wellington, New Zealand, 1998.
9. Kendall, Linton SJ, Main CJ. Guide to assessing psychosocial yellow flags in acute low back pain. Risk factors for long-term disability and work loss. Wellington, New Zealand, Accident Rehabilitation & Compensation Insurance Corporation of New Zealand and the National Health Committee, 1997.
10. Nederlandse Vereniging voor Arbeids- en Bedrijfsgeneeskunde (Dutch Association of Occupational Medicine, NVAB). Handelen van de bedrijfsarts bij werknemers met lage-rugklachten. Richtlijnen voor Bedrijfsartsen. [Dutch guideline for the management of occupational physicians of employees with low back pain]. April 1999.
11. Carter JT, Birell LN. Occupational health guidelines for the management of low back pain at work�principal recommendations. London: Faculty of Occupational Medicine, 2000 (www.facoccmed.ac.uk).
12. Occupational health guidelines for the management of low back pain at work�leaflet for practitioners. London: Faculty of Occupational Medicine, 2000 (www.facoccmed.ac.uk).
13. Waddell G, Burton AK. Occupational health guidelines for the management of low back pain at work�evidence review. Occup Med 2001;51:124�35.
14. Roland M, et al. The back book. Norwich: The Stationery Office, 1996.
15. ICSI. Health care guideline. Adult low back pain. Institute for Clinical Systems Integration, 1998 (www.icsi.org/guide/).
16. Kazimirski JC. CMA policy summary: The physician�s role in helping patients return to work after an illness or injury. CMAJ 1997;156:680A�680C.
17. Yamamoto S. Guidelines on worksite prevention of low back pain. Labour standards bureau notification, No. 57. Industrial Health 1997;35:143�72.
18. INSERM. Les Lombalgies en milieu professionel: quel facteurs de risque et quelle prevention? [Low back pain at the workplace: risk factors and prevention]. Paris: les editions INSERM, Synthese bibliographique realise a la demande de la CANAM, 2000.
19. Lindstro?m I, Ohlund C, Eek C, et al. The effect of graded activity on patients with subacute low back pain: a randomised prospective clinical study with an operant-conditioning behavioural approach. Physical Therapy 1992;72:279�93.
20. Karjalainen K, Malmivaara A, van Tulder M, et al. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain in working-age adults: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 2001;26:262�9.
21. Staal JB, Hlobil H, van Tulder MW, et al. Return-to-work interventions for low back pain: a descriptive review of contents and concepts of working mechanisms. Sports Med 2002;32:251�67.
22. Hoogendoorn WE, van Poppel MN, Bongers PM, et al. Physical load during work and leisure time as risk factors for back pain. Scand J Work Environ Health 1999;25:387�403.
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Spinal Manipulation vs. Mobilization for Cervicogenic Headache in El Paso, TX

by spinedoctors | Chiropractic, Neck Pain, Randomized Controlled Trial

A primary headache is characterized as head pain caused by a headache disorder itself. The three types of primary headache disorders include, migraine, tension-type headaches and cluster headaches. Head pain is a painful and debilitating symptom that can also occur as a result of another underlying cause. A secondary headache is characterized as head pain which occurs due to an injury and/or condition. A spinal misalignment, or subluxation, along the cervical spine, or neck, is commonly associated with a variety of headache symptoms.

Cervicogenic headache is a secondary headache caused by an injury and/or condition affecting the surrounding structures of the cervical spine, or neck. Many healthcare professionals will recommend the use of drugs/medications to help improve headache, however, several alternative treatment options can be safely and effectively used to treat secondary headaches. The purpose of the following article is to demonstrate the impact of upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache.

Upper Cervical and Upper Thoracic Manipulation Versus Mobilization and Exercise in Patients with Cervicogenic Headache: a Multi-Center Randomized Clinical Trial

Abstract

Background: Although commonly utilized interventions, no studies have directly compared the effectiveness of cervical and thoracic manipulation to mobilization and exercise in individuals with cervicogenic headache (CH). The purpose of this study was to compare the effects of manipulation to mobilization and exercise in individuals with CH.
Methods: One hundred and ten participants (n?=?110) with CH were randomized to receive both cervical and thoracic manipulation (n?=?58) or mobilization and exercise (n?=?52). The primary outcome was headache intensity as measured by the Numeric Pain Rating Scale (NPRS). Secondary outcomes included headache frequency, headache duration, disability as measured by the Neck Disability Index (NDI), medication intake, and the Global Rating of Change (GRC). The treatment period was 4 weeks with follow-up assessment at 1 week, 4 weeks, and 3 months after initial treatment session. The primary aim was examined with a 2-way mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between subjects variable and time (baseline, 1 week, 4 weeks and 3 months) as the within subjects variable.
Results: The 2X4 ANOVA demonstrated that individuals with CH who received both cervical and thoracic manipulation experienced significantly greater reductions in headache intensity (p?<?0.001) and disability (p?<?0.001) than those who received mobilization and exercise at a 3-month follow-up. Individuals in the upper cervical and upper thoracic manipulation group also experienced less frequent headaches and shorter duration of headaches at each follow-up period (p?<?0.001 for all). Additionally, patient perceived improvement was significantly greater at 1 and 4-week follow-up periods in favor of the manipulation group (p?<?0.001).
Conclusions: Six to eight sessions of upper cervical and upper thoracic manipulation were shown to be more effective than mobilization and exercise in patients with CH, and the effects were maintained at 3 months.
Trial registration: NCT01580280 April 16, 2012.
Keywords: Cervicogenic headache, Spinal manipulation, Mobilization, High velocity low amplitude thrust

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

In comparison to primary headache, such as migraine, cluster headache and tension-type headache, secondary headache is characterized as head pain caused by another illness or physical issue. In the case of cervicogenic headache, the cause of head pain is due to an injury and/or condition along the cervical spine and its surrounding structures, including the vertebrae, intervertebral discs and soft tissues. In addition, many healthcare professionals believe that primary headache can be associated with health issues in the cervical spine, or neck. Cervicogenic headache treatment should target the source of the symptoms and it can vary depending on the patient. Chiropractic care utilizes spinal adjustments and manual manipulations to carefully restore the original structure and function of the spine, helping to reduce stress and pressure in order to improve cervicogenic headache symptoms, among other type of headache. Chiropractic care can also be utilized to help treat primary headaches, such as migraines.

Background

The International Classification of Headache Disorders defines cervicogenic headache (CH) as, �headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain.� [1] (p.760) The prevalence of CH has been reported to be between 0.4 and 20 % of the headache population [2, 3], and as high as 53 % in patients with headache after whiplash injury [4]. The dominant features of CH usually include: unilaterality of head pain without side-shift, elicitation of pain with external pressure over the ipsilateral upper neck, limited cervical range of motion, and the triggering of attacks by various awkward or sustained neck movements [4, 5].

Individuals with CH are frequently treated with spinal manipulative therapy including both mobilization and manipulation [6]. Spinal mobilization consists of slow, rhythmical, oscillating techniques whereas manipulation consists of high-velocity low-amplitude thrust techniques. [7] In a recent systematic review, Bronfort and colleagues reported that spinal manipulative therapy (both mobilization and manipulation) were effective in the management of adults with CH [8]. However, they did not report if manipulation resulted in superior outcomes compared to mobilization for the management of this population.

Several studies have investigated the effect of spinal manipulation in the management of CH [9�13]. Haas et al. [10] investigated the effectiveness of cervical manipulation in subjects with CH. Jull et al. [11] demonstrated treatment efficacy for manipulative therapy and/or exercise in the management of CH. However the manipulative therapy group included manipulation and mobilization therefore it cannot be determined if the beneficial effect was a result of the manipulation, mobilization or the combination.

A few studies have examined the benefits of manipulation versus mobilization for the management of mechanical neck pain with or without exercise [14�16]. However, no studies have directly compared the effects of manipulation versus mobilization and exercise in patients with CH. Considering the purported risks of manipulation [17], it is essential to determine if manipulation results in improved outcomes compared to mobilization for the management of patients with CH. Therefore, the purpose of this randomized clinical trial was to compare the effects of manipulation versus mobilization and exercise in patients with CH. We hypothesized that patients receiving manipulation over a 4-week treatment period would experience greater reductions in headache intensity, headache frequency, headache duration, disability, and medication intake at a 3-month follow-up than patients receiving cervical and thoracic mobilization combined with exercise.

Methods

Participants

In this multi-center randomized clinical trial, consecutive patients with CH presenting to 1 of 8 outpatient physical therapy clinics from a variety of geographical locations (Arizona, Georgia, New York, Ohio, Pennsylvania, South Carolina) were recruited over a 29-month period (from April 2012 to August 2014). For patients to be eligible, they had to present with a diagnosis of CH according to the revised diagnostic criteria [5] developed by the Cervicogenic Headache International Study Group (CHISG) [5, 18, 19]. CH was classified according to the �major criteria� (not including confirmatory evidence by diagnostic anesthetic blockades) and �head pain characteristics� of the CHISG. Therefore, in order to be included in the study, patients had to exhibit all of the following criteria: (1) unilaterality of the head pain without sideshift, starting in the upper posterior neck or occipital region, eventually spreading to the oculofrontotemporal area on the symptomatic side, (2) pain triggered by neck movement and/or sustained awkward positions, (3) reduced range of motion in the cervical spine [20] (i.e., less than or equal to 32 � of right or left passive rotation on the Flexion-Rotation Test [21�23], (4) pain elicited by external pressure over at least one of the upper cervical joints (C0-3), and (5) moderate to severe, non-throbbing and non-lancinating pain. In addition, participants had to have a headache frequency of at least 1 per week for a minimum of 3 months, a minimum headache intensity pain score of two points (0�10 on the NPRS scale), a minimum disability score of 20 % or greater (i.e., 10 points or greater on the 0�50 NDI scale), and be between 18 and 65 years of age.

Patients were excluded if they exhibited other primary headaches (i.e., migraine, TTH), suffered from bilateral headaches, or exhibited any red flags (i.e., tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.), presented with two or more positive neurologic signs consistent with nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome), presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms, had evidence of central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes), had a history of whiplash injury within the previous 6 weeks, had prior surgery to the head or neck, had received treatment for head or neck pain from any practitioner within the previous month, had received physical therapy or chiropractic treatment for head or neck pain within the previous 3 months, or had pending legal action regarding their head or neck pain.

The most recent literature suggests that pre-manipulative cervical artery testing is unable to identify those individuals at risk of vascular complications from cervical manipulation [24, 25], and any symptoms detected during pre-manipulative testing may be unrelated to changes in blood flow in the vertebral artery [26, 27]. Hence, pre-manipulative cervical artery testing was not performed in this study; however, screening questions for cervical artery disease had to be negative [24, 28, 29]. This study was approved by the Institutional Review Board at Long Island University, Brooklyn, NY. The study was registered at www.clinicaltrials.gov with trial identifier NCT01580280. All patients were informed that they would receive either manipulation or mobilization and exercise and then provided informed consent before their enrollment in the study.

Treating Therapists

Twelve physical therapists (mean age 36.6 years, SD 5.62) participated in the delivery of treatment for patients in this study. They had an average of 10.3 (SD 5.66, range 3�20 years) years of clinical experience, and all had completed a 60 h post-graduate certification program that included practical training in manual techniques including the use of cervical and thoracic manipulation. To ensure all examination, outcome assessments, and treatment procedures were standardized, all participating physical therapists were required to study a manual of standard operating procedures and participate in a 4 h training session with the principal investigator.

Examination Procedures

All patients provided demographic information, completed the Neck Pain Medical Screening Questionnaire, and completed a number of self-report measures, followed by a standardized history and physical examination at baseline. Self-report measures included headache intensity as measured by the NPRS (0�10), the NDI (0�50), headache frequency (number of days with headache in the last week), headache duration (total hours of headache in the last week), and medication intake (number of times the patient had taken narcotic or over-the-counter pain medication in the past week).

The standardized physical examination was not limited to, but included measurements of C1-2 (atlanto-axial joint) passive right and left rotation ROM using the Flexion-Rotation Test (FRT). The inter-rater reliability for the FRT has been found to be excellent (ICC: 0.93; 95 % CI: 0.87, 0.96) [30].

Outcome Measures

The primary outcome measure used in this study was the patient�s headache intensity as measured by the NPRS. Patients were asked to indicate the average intensity of headache pain over the past week using an 11-point scale ranging from 0 (�no pain�) to 10 (�worst pain imaginable�) at baseline, 1-week, 1-month, and 3-months following the initial treatment session [31]. The NPRS is a reliable and valid instrument to assess pain intensity [32�34]. Although no data exists in patients with CH, the MCID for the NPRS has been shown to be 1.3 in patients with mechanical neck pain [32] and 1.74 in patients with a variety of chronic pain conditions [34]. Therefore, we chose to only include patients with an NPRS score of 2 points (20 %) or greater.

Secondary outcome measures included the NDI, the Global Rating of Change (GRC), headache frequency, headache duration, and medication intake. The NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain [35�37]. The NDI is a self-report questionnaire with 10-items rated from 0 (no disability) to five (complete disability) [38]. The numeric responses for each item are summed for a total score ranging between 0 and 50; however, some evaluators have chosen to multiply the raw score by two, and then report the NDI on a 0�100 % scale [36, 39]. Higher scores represent increased levels of disability. The NDI has been found to possess excellent test-retest reliability, strong construct validity, strong internal consistency and good responsiveness in assessing disability in patients with mechanical neck pain [36], cervical radiculopathy [33, 40], whiplash associated disorder [38, 41, 42], and mixed non-specific neck pain [43, 44]. Although no studies have examined the psychometric properties of the NDI in patients with CH, we chose to only include patients with an NDI score of ten points (20 %) or greater, because this cut-off score captures the MCID for the NDI, which has been reported to approximate four, eight, and nine points (0�50) in patients with mixed non-specific neck pain [44], mechanical neck pain [45], and cervical radiculopathy [33], respectively. Headache frequency was measured as the number of days with headache in the last week, ranging from 0 to 7 days. Headache duration was measured as the total hours of headache in the last week, with six possible ranges: (1) 0�5 h, (2) 6�10 h, (3) 11�15 h, (4) 16�20 h, (5) 21�25 h, or (6) 26 or more hours. Medication intake was measured as the number of times the patient had taken prescription or over-the-counter analgesic or anti-inflammatory medication in the past week for their headaches, with five options: (1) not at all, (2) once a week, (3) once every couple of days, (4) once or twice a day, or (5) three or more times a day.

Patients returned for 1-week, 4-weeks, and 3-months follow-ups where the aforementioned outcome measures were again collected. In addition, at the 1-week, 4-weeks and 3-months follow-ups, patients completed a 15-point GRC question based on a scale described by Jaeschke et al. [46] to rate their own perception of improved function. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6, respectively. The MCID for the GRC has not been specifically reported but scores of +4 and +5 have typically been indicative of moderate changes in patient status [46]. However, it should be noted that recently Schmitt and Abbott reported that the GRC might not correlate with changes in function in a population with hip and ankle injuries [47]. All outcome measures were collected by an assessor blind to group assignment.

On the initial visit patients completed all outcome measures then received the first treatment session. Patients completed 6�8 treatment sessions of either manipulation or mobilization combined with exercise over 4 weeks. Additionally, subjects were asked if they had experienced any �major� adverse events [48, 49] (stroke or permanent neurological deficits) at each follow-up period.

Randomization

Following the baseline examination, patients were randomly assigned to receive either manipulation or mobilization and exercise. Concealed allocation was performed by using a computer-generated randomized table of numbers created by an individual not involved with recruiting patients prior to the beginning of the study. Individual, sequentially numbered index cards with the random assignment were prepared for each of 8 data collection sites. The index cards were folded and placed in sealed opaque envelopes. Blinded to the baseline examination, the treating therapist opened the envelope and proceeded with treatment according to the group assignment. Patients were instructed not to discuss the particular treatment procedure received with the examining therapist. The examining therapist remained blind to the patient�s treatment group assignment at all times; however, based on the nature of the interventions it was not possible to blind patients or treating therapists.

Manipulation Group

Manipulations targeting the right and left C1-2 articulations and bilateral T1-2 articulations were performed on at least one of the 6�8 treatment sessions (Figs. 1 and ?and2).2). On other treatment sessions, therapists either repeated the C1-2 and/or T1-2 manipulations or targeted other spinal articulations (i.e., C0-1, C2-3, C3-7, T2-9, ribs 1�9) using manipulation. The selection of the spinal segments to target was left to the discretion of the treating therapist and it was based on the combination of patient reports and manual examination. For both the upper cervical and upper thoracic manipulations, if no popping or cracking sound was heard on the first attempt, the therapist repositioned the patient and performed a second manipulation. A maximum of 2 attempts were performed on each patient similar to other studies [14, 50�53]. The clinicians were instructed that the manipulations are likely to be accompanied by multiple audible popping sounds [54�58]. Patients were encouraged to maintain usual activity within the limits of pain; however, mobilization and the prescription of exercises, or any use of other modalities, were not provided to this group.

Figure 1 HVLA Thrust Manipulation Directed to the right C1-2 Articulation | El Paso, TX Chiropractor

Figure 2 HVLA Thrust Manipulation Directed Bilaterally to the Upper Thoracic Spine | El Paso, TX Chiropractor

The manipulation targeting C1-2 was performed with the patient in supine. For this technique, the patient�s left posterior arch of the atlas was contacted with the lateral aspect of the proximal phalanx of the therapist�s left second finger using a �cradle hold�. To localize the forces to the left C1-2 articulation, the patient was positioned using extension, a posterior-anterior (PA) shift, ipsilateral side-bend and contralateral side-shift. While maintaining this position, the therapist performed a single high-velocity, low-amplitude thrust manipulation to the left atlanto-axial joint using right rotation in an arc toward the underside eye and translation toward the table (Fig. 1). This was repeated using the same procedure but directed to the right C1-2 articulation.

The manipulation targeting T1-2 was performed with the patient in supine. For this technique, the patient held her/his arms and forearms across the chest with the elbows aligned in a superoinferior direction. The therapist contacted the transverse processes of the lower vertebrae of the target motion segment with the thenar eminence and middle phalanx of the third digit. The upper lever was localized to the target motion segment by adding rotation away and side-bend towards the therapist while the underside hand used pronation and radial deviation to achieve rotation toward and side-bend away moments, respectively. The space inferior to the xiphoid process and costochondral margin of the therapist was used as the contact point against the patient�s elbows to deliver a manipulation in an anterior to posterior direction targeting T1-2 bilaterally (Fig. 2).

Mobilization and Exercise Group

Mobilizations targeting the right and left C1-2 articulations and bilateral T1-2 articulations were performed on at least one of the 6�8 treatment sessions. On other treatment sessions, therapists either repeated the C1-2 and/or T1-2 mobilizations or targeted other spinal articulations (i.e., C0-1, C2/3, C3-7, T2-9, ribs 1�9) using mobilization. The selection of the spinal segments to target was left to the discretion of the treating therapist and it was based on the combination of patient reports and manual examination. However, in order to avoid a �contact� or �attention effect� when compared with the manipulation group, therapists were instructed to mobilize one cervical segment (i.e., right and left) and one thoracic segment or rib articulation on each treatment session.

The mobilization targeting the C1-2 articulation was performed in prone. For this technique, the therapist performed one 30 s bout of left-sided unilateral grade IV PA mobilizations to the C1-2 motion segment as described by Maitland [7]. This same procedure was repeated for one 30 s bout to the right atlanto-axial joint. In addition, and on at least one session, mobilization directed to the upper thoracic (T1-2) spine with the patient prone was performed. For this technique, the therapist performed one 30 s bout of central grade IV PA mobilizations to the T1-2 motion segment as described by Maitland [7]. Therefore, we used 180 (i.e., three 30 s bouts at approximately 2 Hz) end-range oscillations in total on each subject for the mobilization treatment. Notably, there is no high quality evidence to date to suggest that longer durations of mobilization result in greater pain reduction than shorter durations or dosages of mobilization [59, 60].

Cranio-cervical flexion exercises [11, 61�63] were performed with the patient in supine, with the knees bent and the position of the head standardized by placing the craniocervical and cervical spines in a mid-position, such that a line between the subject�s forehead and chin was horizontal, and a horizontal line from the tragus of the ear bisected the neck longitudinally. An air-filled pressure biofeedback unit (Chattanooga Group, Inc., Hixson, TN) was placed suboccipitally behind the patient�s neck and preinflated to a baseline of 20 mmHg [63]. For the staged exercises, patients were required to perform the craniocervical flexion action (�a nod of the head, similar to indicating yes�) [63] and attempt to visually target pressures of 22, 24, 26, 28, and 30 mmHg from a resting baseline of 20 mmHg and to hold the position steady for 10 s [61, 62]. The action of nodding was performed in a gentle and slow manner. A 10 s rest was allowed between trials. If the pressure deviated below the target pressure, the pressure was not held steady, substitution with the superficial flexors (sternocleidomastoid or anterior scalene) occurred, or neck retraction was noticed before the completion of the 10 s isometric hold, it was regarded as a failure [63]. The last successful target pressure was used to determine each patient�s exercise level wherein 3 sets of 10 repetitions with a 10 s isometric hold were performed. In addition to mobilizations and cranio-cervical flexion exercises, patients were required to perform 10 min of progressive resistance exercises (i.e., using Therabands� or free weights) to the muscles of the shoulder girdle during each treatment session, within their own tolerance, and specifically focusing on the lower trapezius and serratus anterior [11].

Sample Size

The sample size and power calculations were performed using online software from the MGH Biostatistics Center (Boston, MA). The calculations were based on detecting a 2-point (or 20 %) difference in the NPRS (headache intensity) at the 3 months follow-up, assuming a standard deviation of three points, a 2-tailed test, and an alpha level equal to 0.05. This generated a sample size of 49 patients per group. Allowing for a conservative dropout rate of 10 %, we planned to recruit at least 108 patients into the study. This sample size yielded greater than 90 % power to detect a statistically significant change in the NPRS scores.

Data Analysis

Descriptive statistics, including frequency counts for categorical variables and measures of central tendency and dispersion for continuous variables were calculated to summarize the data. The effects of treatment on headache intensity and disability were each examined with a 2-by-4 mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization and exercise) as the between-subjects variable and time (baseline, 1 week, 4 weeks, and 3 months follow-up) as the within-subjects variable. Separate ANOVAs were performed with the NPRS (headache intensity) and NDI (disability) as the dependent variable. For each ANOVA, the hypothesis of interest was the 2-way interaction (group by time).

An independent t-test was used to determine the between group differences for the percentage change from baseline to 3-month follow-up in both headache intensity and disability. Separate Mann�Whitney U tests were performed with the headache frequency, GRC, headache duration and medication intake as the dependent variable. We performed Little�s Missing Completely at Random (MCAR) test [64] to determine if missing data points associated with dropouts were missing at random or missing for systematic reasons. Intention-to-treat analysis was performed by using Expectation-Maximization whereby missing data are computed using regression equations. Planned pairwise comparisons were performed examining the difference between baseline and follow-up periods between-groups using the Bonferroni correction at an alpha level of .05.

We dichotomized patients as responders at the 3-month follow-up using a cut score of 2 points improvement for headache intensity as measured by the NPRS. Numbers needed to treat (NNT) and 95 % confidence intervals (CI) were also calculated at the 3 months follow-up period using each of these definitions for a successful outcome. Data analysis was performed using SPSS 21.0.

Results

Two hundred and fifty-one patients with a primary complaint of headaches were screened for possible eligibility. The reasons for ineligibility can be found in Fig. 3, the flow diagram of patient recruitment and retention. Of the 251 patients screened, 110 patients, with a mean age of 35.16 years (SD 11.48) and a mean duration of symptoms of 4.56 years (SD 6.27), satisfied the eligibility criteria, agreed to participate, and were randomized into manipulation (n?=?58) and mobilization and exercise (n?=?52) groups. Baseline variables for each group can be found in Table 1. Twelve therapists from 8 outpatient physical therapy clinics each treated 25, 23, 20, 14, 13, 7, 6 or 2 patients, respectively; furthermore, each of the 12 therapists treated approximately an equal proportion of patients in each group. There was no significant difference (p?=?0.227) between the mean number of completed treatment sessions for the manipulation group (7.17, SD 0.96) and the mobilization and exercise group (6.90, SD 1.35). In addition, the mean number of treatment sessions that targeted the C1-2 articulation was 6.41 (SD 1.63) for the manipulation group and 6.52 (SD 2.01) for the mobilization and exercise group, and this was not significantly different (p?=?0.762). One hundred seven of the 110 patients completed all outcome measures through 3 months (97 % follow-up). Little�s Missing Completely at Random (MCAR) test was not statistically significant (p?=?0.281); therefore, we used the Expectation-Maximization imputation technique to replace missing values with predicted values for the missing 3-month outcomes.

Figure 3 Flow Diagram of Patient Recruitment and Retention | El Paso, TX Chiropractor

Table 1 Baseline Variables, Demographics and Outcome Measures | El Paso, TX Chiropractor

The overall group by time interaction for the primary outcome of headache intensity was statistically significant for the NPRS (F(3,106)?=?11.196; p?<?0.001; partial eta squared?=?0.24). Between-group differences revealed that the manipulation group experienced statistically significant greater improvement in the NPRS at both the 1-week (2.1, 95 % CI: 1.2, 2.9), 4-week (2.3, 95 % CI: 1.5, 3.1) and 3-month (2.1, 95 % CI: 1.2, 3.0) follow-up periods (Table 2). In addition, an independent samples t-test revealed the between-group difference in percentage change in headache intensity (36.58 %, 95 % CI: 22.52, 50.64) from baseline to 3-month follow-up was statistically significant (t(108)?=?5.156; p?<?0.001) in favor of manipulation. See Table 3 for the percentage of subjects gaining 50, 75, and 100 % reduction in headache intensity at 3 months.

Table 2 Changes in Headache Intensity and Disability | El Paso, TX Chiropractor

Table 3 Percentage of Subjects Gaining 50, 75, and 100 Percent Reduction | El Paso, TX Chiropractor

For secondary outcomes a significant group by time interaction existed for the NDI (F(3,106)?=?8.57; p?<?0.001; partial eta squared?=?0.20). At each follow-up period the manipulation group had superior outcomes in disability reduction as compared to the mobilization and exercise group. An independent samples t- test revealed the between-group mean percentage change in disability (35.56 %, 95 % CI: 24.95, 46.17) from baseline to 3 months follow-up was statistically significant (t(108)?=?6.646, p?<?0.001); indicating the manipulation group experienced a significantly greater percentage in disability reduction (Table 3).

Mann�Whitney U tests revealed that patients in the upper cervical and upper thoracic manipulation group experienced less frequent headaches at 1 week (p?<?0.001; median 2.0 versus 3.0), 4 weeks (p?<?0.001; median 1.0 versus 3.0) and 3 months (p?<?0.001; median 1.0 versus 2.5) than patients in the mobilization and exercise group. Headache duration was significantly lower at 1 week (p?=?0.005; median 2.0 versus 3.0, 4 weeks (p?<?0.001; median 1.0 versus 2.0) and 3 months (p?<?0.001; median 1.0 versus 2.0) in the manipulation group. Additionally, patient perceived improvement as measured by the GRC was significantly greater at 1 week (p?<?0.001, 4.0 versus 1.0), 4 weeks (p?<?0.001, 6.0 versus 3.0) and 3 months (p?<?0.001, 6.0 versus 3.0) than patients in the mobilization and exercise group. At 3 months, patients receiving upper cervical and upper thoracic manipulation experienced significantly (p?<?0.001) greater reductions in medication intake as compared to the mobilization and exercise group. Based on the cutoff score of 2 points on the NPRS, the NNT was 4.0 (95 % CI: 2.3, 7.7) in favor of the manipulation group at 3-month follow-up.

We did not collect any data on the occurrence of �minor� adverse events [48, 49] (transient neurological symptoms, increased stiffness, radiating pain, fatigue or other); however, no �major� adverse events [48, 49] (stroke or permanent neurological deficits) were reported for either group.

Discussion

Statement of Principal Findings

To our knowledge, this study is the first randomized clinical trial to directly compare the effectiveness of both cervical and thoracic manipulation to mobilization and exercise in patients with CH. The results suggest 6�8 sessions of manipulation over 4 weeks, directed mainly to both the upper cervical (C1-2) and upper thoracic (T1-2) spines, resulted in greater improvements in headache intensity, disability, headache frequency, headache duration, and medication intake than mobilization combined with exercises. The point estimates for between-group changes in headache intensity (2.1 points) and disability (6.0 points or 12.0 %) exceeded the reported MCIDs for both measures. Although the MCID for the NDI in patients with CH has not yet been investigated, it should however be noted that the lower bound estimate of the 95 % CI for disability (3.5 points) was slightly below (or approximated in two cases) the MCID that has been found to be 3.5 [65], 5 [66], and 7.5 [45] points in patients with mechanical neck pain, 8.5 [33] points in patients with cervical radiculopathy, and 3.5 [44] points in patients with mixed, non-specific neck pain. However, it should be recognized that both groups made clinical improvement. In addition, the NNT suggests for every four patients treated with manipulation, rather than mobilization, one additional patient achieves clinically important pain reduction at 3 months follow-up.

Strengths and Weaknesses of the Study

The inclusion of 12 treating physical therapists from 8 private clinics in 6 different geographical states enhances the overall generalizability of our findings. Although significant differences were recognized up to 3 months, it is not known if these benefits would have been sustained at long-term. In addition, we used high-velocity, low-amplitude manipulation techniques that employed bidirectional thrusts into rotation and translation simultaneously and Maitland based grade IV PA mobilization techniques; thus, we cannot be certain that these results are generalizable to other kinds of manual therapy techniques. Some might argue that the comparison group might have not received adequate intervention. We sought to balance internal and external validity so standardized treatment for both groups and provided a very explicit description of the techniques used which will also allow for replication. Furthermore, we did not measure minor adverse events and only asked about two potential major adverse events. Another limitation is that we included multiple secondary outcomes. Therapist preferences as to which technique they thought would be superior was not collected and potentially could impact the results.

Strengths and Weaknesses in Relation to Other Studies: Important Differences in Results

Jull et al. [11] demonstrated treatment efficacy for manipulative therapy and exercise in the management of CH; however, this treatment package included both mobilization and manipulation. The current study may provide evidence that the management of patients with CH should include some form of manipulation despite the fact it is often suggested that cervical manipulation should be avoided because of the risk of serious adverse events [67, 68]. Furthermore, it has been shown that individuals receiving spinal manipulation for neck pain and headaches are no more likely to experience a vertebrobasilar stroke than if they received treatment by their medical physician [69]. Additionally, after reviewing 134 case reports, Puentedura et al. concluded that with appropriate selection of patients by careful screening of red flags and contraindications, the majority of adverse events associated with cervical manipulation could have been prevented [70].

Meaning of the Study: Possible Explanations and Implications for Clinicians and Policymakers

Based on the results of the current study clinicians should consider incorporating spinal manipulation for individuals with CH. A recent systematic review found both mobilization and manipulation to be effective for the management of patients with CH but was unable to determine which technique was superior [8]. Additionally, clinical guidelines reported that manipulation, mobilization and exercise were all effective for the management of patients with CH; however, the guideline made no suggestions regarding the superiority of either technique. [71] The current results may assist authors of future systematic reviews and clinical guidelines in providing more specific recommendations about the use of spinal manipulation in this population.

Unanswered Questions and Future Research

The underlying mechanisms as to why manipulation may have resulted in greater improvements remains to be elucidated. It has been suggested that high-velocity displacement of vertebrae with impulse durations of less than 200 ms may alter afferent discharge rates [72] by stimulating mechanoreceptors and proprioceptors, thereby changing alpha motorneuron excitability levels and subsequent muscle activity [72�74]. Manipulation might also stimulate receptors in the deep paraspinal musculature, and mobilization might be more likely to facilitate receptors in the superficial muscles [75]. Biomechanical [76, 77], spinal or segmental [78, 79] and central descending inhibitory pain pathway [80�83] models are plausible explanations for the hypoalgesic effects observed following manipulation. Recently, the biomechanical effects of manipulation have been under scientific scrutiny [84], and it is plausible that the clinical benefits found in our study are associated with a neurophysiological response involving temporal sensory summation at the dorsal horn of the spinal cord [78]; however, this proposed model is currently supported only on findings from transient, experimentally induced pain in healthy subjects [85, 86], not patients with CH. Future studies should examine different manual therapy techniques with varying dosages and include a 1-year follow-up. Furthermore, future studies examining the neurophysiological effects of both manipulation and mobilization will be important for determining why there may or may not be a difference in clinical effects between these two treatments.

Conclusion

The results of the current study demonstrated that patients with CH who received cervical and thoracic manipulation experienced significantly greater reductions in headache intensity, disability, headache frequency, headache duration, and medication intake as compared to the group that received mobilization and exercise; furthermore, the effects were maintained at 3 months follow-up. Future studies should examine the effectiveness of different types and dosages of manipulation and include a long-term follow-up.

Acknowledgements

None of the authors received any funding for this study. The authors wish to thank all the participants of the study.

Footnotes

Competing interests: Dr. James Dunning is the President of the American Academy of Manipulative Therapy (AAMT). AAMT provides postgraduate training programs in spinal manipulation, spinal mobilization, dry needling, extremity manipulation, extremity mobilization, instrument-assisted soft-tissue mobilization and therapeutic exercise to licensed physical therapists, osteopaths and medical doctors. Drs. James Dunning, Raymond Butts, Thomas Perreault, and Firas Mourad are senior instructors for AAMT. The other authors declare that they have no competing interests.
Authors� contributions: JRD participated in the conception, design, data acquisition, statistical analyses and drafting of the manuscript. RB and IY participated in the design, data collection, statistical analyses and revision of the manuscript. FM participated in the design, statistical analyses, data interpretation and revision of the manuscript. MH participated in the conception, design and revision of the manuscript. CF and JC were involved in the statistical analyses, interpretation of data, and critical revision of the manuscript for important intellectual content. TS, JD, DB, and TH were involved in data collection and revision of the manuscript. All authors read and approved the final manuscript.

Contributor Information

Ncbi.nlm.nih.gov/pmc/articles/PMC4744384/

In conclusion,�head pain caused by secondary headache due to a health issue along the surrounding structures of the cervical spine, or neck, can cause painful and debilitating symptoms which can affect the patient’s quality of life. Spinal manipulation and mobilization can be safely and effectively utilized to help improve cervicogenic headache 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

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