Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study.

OBJECTIVES: The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients. SETTING: University-initiated international survey. PARTICIPANTS: The expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers. PROCEDURES: The initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools. RESULTS: Results suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks. CONCLUSIONS: Recommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication. TRIAL REGISTRATION NUMBER: German Register of Clinical Trials (DRKS00011777).

The chiropractic workforce: a global review.

Background: The world is faced with a chronic shortage of health workers, and the World Health Organization (WHO) has estimated a global shortage of 7.2 million health workers resulting in large gaps in service provision for people with disability. The magnitude of the unmet needs, especially within musculoskeletal conditions, is not well established as global data on health work resources are scarce. Methods: We conducted an international, cross-sectional survey of all 193 United Nation member countries and seven dependencies to describe the global chiropractic workforce in terms of the availability (numbers and where they are practising), quality (education and licensing), accessibility (entry and reimbursement), and acceptability (scope of practice and legal rights). An electronic survey was issued to contact persons of constituent member associations of the World Federation of Chiropractic (WFC). In addition, data were collected from government websites, personal communication and internet searches. Data were analysed using descriptive statistics. Worldwide density maps of the distribution of numbers of chiropractors and providers of chiropractic education were graphically presented. Results: Information was available from 90 countries in which at least one chiropractor was present. The total number of chiropractors worldwide was 103,469. The number of chiropractors per country ranged from 1 to 77,000 (median = 10; IQR = [4-113]). Chiropractic education was offered in 48 institutions in 19 countries. Direct access to chiropractic services was available in 81 (90%) countries, and services were partially or fully covered by government and/or private health schemes in 46 (51.1%) countries. The practice of chiropractic was legally recognized in 68 (75.6%) of the 90 countries. It was explicitly illegal in 12 (13.3%) countries. Conclusion: We have provided information about the global chiropractic workforce. The profession is represented in 90 countries, but the distribution of chiropractors and chiropractic educational institutions, and governing legislations and regulations largely favour high-income countries. There is a large under-representation in low- and middle-income countries in terms of provision of services, education and legislative and regulatory frameworks, and the available data from these countries are limited.

Workplace Factors Associated With Neck Pain Experienced by Computer Users: A Systematic Review.

INTRODUCTION: The purpose of this systematic review was to examine literature on workplace factors associated with neck pain or symptoms in computer users performing clerical functions. METHODS: A systematic search of the Cochrane, Medline, CINAHL, and EMBASE databases was conducted for observational and experimental studies published since 2000. This review applied the case definition of The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. RESULTS: Seven hundred twenty-nine studies were identified. Seven hundred and two studies were excluded. Twenty-seven studies fulfilled inclusion criteria and were assessed for risk of bias. Cross-sectional studies were commonly at risk from nonresponse bias and lack of adequate case definitions. Experimental studies were mostly at risk of bias due to confounding and participant recruitment methods. CONCLUSIONS: Neck pain was not significantly associated with high job demands, low skill discretion, low decision authority, or low peer support. However, when these variables were combined with increased duration of computing tasks, or ergonomic demands, they reached significance. Supervisor support was found to be the only significant buffer capable of preventing these variables reaching significance in female office workers.

The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

OBJECTIVES: The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). METHODS: A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. RESULTS: The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. CONCLUSIONS: A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required.

Chiropractic curriculum mapping and congruence of the evidence for workplace interventions in work-related neck pain.

OBJECTIVE: The purpose of this study was to provide a best-synthesis summary of the literature for effective workplace health promotion interventions (WHPI) for work-related mechanical neck pain (MNP) and to determine the congruence between knowledge of WHPI for work-related MNP and coverage of MNP in the chiropractic postgraduate program at Macquarie University. METHODS: A literature review was undertaken to determine effective WHPI for work-related MNP. We searched Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro (from 1991 to 2016) for systematic reviews and meta-analyses. The PRISMA (2009) 27-item checklist was used to critically appraise included articles. Lectures, tutorials, and assessment tasks within the chiropractic postgraduate program were mapped to the literature review findings and analyzed. RESULTS: There was moderate-quality evidence for multidimensional WHPI, including aspects of mental and physical functioning, activity performance and modifications, and environmental modifications, to reduce MNP and disability in workers, particularly in the long term. Education on coverage of MNP and effective WHPI for MNP was inadequately covered although congruent with synthesis of current literature. Education on body functions and structures and personal factors were the most commonly covered components. CONCLUSION: Multidimensional WHPI, focusing on physical, mental, and environmental modifications, appear to reduce self-reported MNP primarily in office workers. There is adequate congruence between the chiropractic postgraduate program at Macquarie University and the published literature on some WHPI. However, there is inadequate coverage on aspects of MNP and effective WHPI for MNP, particularly those focusing on activity and participation and environmental factors.

Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial.

OBJECTIVE: Cervicogenic headache is a disabling headache where pharmacological management have limited effect. Thus, non-pharmacological management is warranted. Our objective was therefore to investigate the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continued usual but non-manual management) for cervicogenic headache in a prospective 3-armed single-blinded, placebo, randomized controlled trial of 17 months' duration. RESULTS: Nineteen participants were equally randomized into the three groups, and 12 participants completed the randomized controlled trial. Headache frequency improved at all time points in the chiropractic spinal manipulative therapy and the placebo group. Headache index improved in the chiropractic spinal manipulative therapy group at all time points, while it improved at 6 and 12 months' follow-up in the placebo group. The control group remained unchanged during the whole study period. Adverse events were few, mild and transient. Blinding was concealed throughout the RCT. Thus, our results suggest that manual-therapy might be a safe treatment option for participants with cervicogenic headache, but data need to be confirmed in a randomized controlled trial with sufficient sample size and statistical power. Trial registration ClinicalTrials.gov identifier: NCT01687881, 11 September 2012.

Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs.

BACKGROUND: Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal. OBJECTIVE: To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT. DESIGN: A prospective 3-armed, single-blinded, placebo, RCT. METHODS: Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs. RESULTS: AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0). CONCLUSIONS: AEs were mild and transient, and severe or serious AEs were not observed.

Letter to the Editor.

In reviewing Melikyan et al., we discuss what we think are weaknesses in the case report. The authors did not report on known risk factors for cerebrovascular accident and vertebral artery dissection. Known symptoms that appear early in vertebral artery dissection were not reported or denied, specifically related to changes in the patient's pattern of neck pain. Causality was assumed when only a weak temporal relation was involved. Finally, the case report makes it appear that the manipulation was performed by someone other than a chiropractor but therefore erroneously uses chiropractic in the title.

Chiropractic Management of Pregnancy-Related Lumbopelvic Pain: A Case Study.

OBJECTIVE: The purpose of this case report is to describe chiropractic management of a patient with pregnancy-related lumbopelvic pain. CLINICAL FEATURES: A pregnant 35-year-old woman experienced insidious moderate to severe pregnancy-related lumbopelvic pain and leg pain at 32 weeks' gestation. Pain limited her endurance capacity for walking and sitting. Clinical testing revealed a left sacroiliac joint functional disturbance and myofascial trigger points reproducing back and leg pain. INTERVENTION AND OUTCOME: A diagnosis of pregnancy-related low back pain and pregnancy-related pelvic girdle pain was made. The patient was treated with chiropractic spinal manipulation, soft tissue therapy, exercises, and ergonomic advice in 13 visits over 6 weeks. She consulted her obstetrician for her weekly obstetric visits. At the end of treatment, her low back pain reduced from 7 to 2 on a 0-10 numeric pain scale rating. Functional activities reported such as walking, sitting, and traveling comfortably in a car had improved. CONCLUSION: This patient with pregnancy-related lumbopelvic pain improved in pain and function after chiropractic treatment and usual obstetric management.

Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial.

Cervicogenic headache (CEH) is a secondary headache which affects 1.0-4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized into one of three groups; CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical trial guidelines by the International Headache Society. Trial registration ClinicalTrials.gov identifier: NCT01687881, 2 December 2012.

Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial.

INTRODUCTION: Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). METHOD AND ANALYSIS: According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. ETHICS AND DISSEMINATION: The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT01741714.

Attitudes and beliefs of Australian chiropractors' about managing back pain: a cross-sectional study.

BACKGROUND: Chiropractors are frequent providers of care for patients with lower back pain. Biopsychosocial approaches to managing patients are regarded as best practice and are gaining wider acceptance. Recent evidence suggests that practitioners' attitudes and beliefs may also have an important effect on patients' recovery from back pain. Past studies have pooled manual therapists from differing professions. Dissonant findings have been hypothesised as being a result of the chiropractic subpopulation within multi-practitioner participant pools who are hypothesised to focus on biomedical aspects of treatment and minimize biopsychosocial dimensions. The aim of this study is to determine whether a study population of only chiropractors would demonstrate similar attitudes and beliefs to other manual therapists' biopsychosocial or biomedical approach to the management of their patients. METHODS: A survey of chiropractors in Victoria Australia in September 2010 was undertaken utilising the Pain Attitude and Belief Scale (PABS.PT), a tool which has been developed to determine the orientation (biopsychosocial or biomedical approach) of practitioners to the management of people with low back pain. The survey also obtained demographic data from respondents to determine whether variables such as education, gender or practice related factors influenced their orientation. RESULTS: The overall response rate was 29% (n = 218). The majority of the sample was male (68%), with a mean age of 44 years. The 6 point Likert scale scores were 34.5 (6.3) for the biomedical factor scale and 31.4 (4.1) for the biopsychosocial scale. Internal consistency of the psychosocial subscale was poor. None of the demographic variables were found to influence the biomedical or psychosocial scales. CONCLUSIONS: Chiropractors in the state of Victoria were found to have similar biomedical and psychosocial orientations in their attitudes and beliefs when compared to other manual therapists' levels of previous studies from differing cultural and educational backgrounds. This study was unable to replicate any of the relationships from past studies with any of the demographic variables. The psychosocial scale internal consistency may be a significant factor in this non-finding. Future research should address the identification of more robust items of the biopsychosocial attitudes of Victorian chiropractors toward treating lower back pain.

A web-based survey of the motivations and challenges faced by emerging researchers in the chiropractic profession.

OBJECTIVE: To investigate the motivations, challenges and perceptions of the educational environment of emerging researchers in chiropractic. METHODS: A descriptive web-based survey of higher-degree chiropractic research students was performed between October and November 2013. The survey consisted of open and closed questions and the Dundee Ready Education Environment Measure. RESULTS: Twenty-two students currently enrolled in a higher-degree research program participated. Students were most commonly enrolled in a doctor of philosophy program at a part-time rate. Motivations of research were desire to improve the clinical care aspects of chiropractic for the public and belief that chiropractic research is lacking. The greatest challenges were the negative attitudes towards chiropractic, finding enough time to do everything required, and feelings of isolation. The higher-degree research educational environment was perceived to be more positive than negative, with the stimulating nature of research a positive feature. A negative feature of the educational environment was poor undergraduate preparation for higher-degree research. CONCLUSION: This study is the first study to describe higher-degree chiropractic research students. Primary motivations included building research, while challenges included not only negative attitudes toward the chiropractic profession but also negative attitudes toward researchers from within the profession. The higher-degree research educational environment was perceived to be positive. By acknowledging the issues that surround emerging researchers in chiropractic, the profession is better placed to foster academics and build research capacity.