Increase in ACC GABA+ levels correlate with decrease in migraine frequency, intensity and disability over time.

BACKGROUND: An imbalance between inhibitory and excitatory neurometabolites has been implicated in chronic pain. Prior work identified elevated levels of Gamma-aminobutyric acid + macromolecules ("GABA+") using magnetic resonance spectroscopy (MRS) in people with migraine. What is not understood is whether this increase in GABA+ is a cause, or consequence of living with, chronic migraine. Therefore, to further elucidate the nature of the elevated GABA+ levels reported in migraine, this study aimed to observe how GABA+ levels change in response to changes in the clinical characteristics of migraine over time. METHODS: We observed people with chronic migraine (ICHD-3) over 3-months as their treatment was escalated in line with the Australian Pharmaceutical Benefits Scheme (PBS). Participants underwent an MRS scan and completed questionnaires regarding migraine frequency, intensity (HIT-6) and disability (WHODAS) at baseline and following the routine 3 months treatment escalation to provide the potential for some participants to recover. We were therefore able to monitor changes in brain neurochemistry as clinical characteristics potentially changed over time. RESULTS: The results, from 18 participants who completed both baseline and follow-up measures, demonstrated that improvements in migraine frequency, intensity and disability were associated with an increase in GABA+ levels in the anterior cingulate cortex (ACC); migraine frequency (r = - 0.51, p = 0.03), intensity (r = - 0.51, p = 0.03) and disability (r = - 0.53, p = 0.02). However, this was not seen in the posterior cingulate gyrus (PCG). An incidental observation found those who happened to have their treatment escalated with CGRP-monoclonal antibodies (CGRP-mAbs) (n = 10) had a greater increase in ACC GABA+ levels (mean difference 0.54 IU IQR [0.02 to 1.05], p = 0.05) and reduction in migraine frequency (mean difference 10.3 IQR [2.52 to 18.07], p = 0.01) compared to those who did not (n = 8). CONCLUSION: The correlation between an increase in ACC GABA+ levels with improvement in clinical characteristics of migraine, suggest previously reported elevated GABA+ levels may not be a cause of migraine, but a protective mechanism attempting to suppress further migraine attacks.

Clinimetric Properties of Self-reported Disability Scales for Whiplash: A Systematic Review for the Whiplash Core Outcome Set (CATWAD).

OBJECTIVES: A core outcomes set (COS) for whiplash-associated disorders (WADs) has been proposed to improve consistency of outcome reporting in clinical trials. Patient-reported disability was one outcome of interest within this COS. The aim of this review was to identify the most suitable tools for measuring self-reported disability in WAD based on clinimetric performance. METHODS: Database searches took place in 2 stages. The first identified outcome measures used to assess self-reported disability in WAD, and the second identified studies assessing the clinimetric properties of these outcome measures in WAD. Data on the study, population and outcome measure characteristics were extracted, along with clinimetric data. Quality and clinimetric performance were assessed in accordance with the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN). RESULTS: Of 19,663 records identified in stage 1 searches, 32 were retained following stage 2 searches and screening. Both the Whiplash Disability Questionnaire and Neck Disability Index performed well in reliability (intraclass correlation coefficient=0.84 to 0.98), construct validity (74% to 82% of hypotheses accepted), and responsiveness (majority of correlations in accordance with hypotheses). Both received Category B recommendations due to a lack of evidence for content validity. DISCUSSION: This review identified the Neck Disability Index and Whiplash Disability Questionnaire as the most appropriate patient-reported outcome measures (PROMs) for assessing self-reported disability in WAD based on moderate to high-quality evidence for sufficient reliability, construct validity and responsiveness. However, the content validity of these PROMs has yet to be established in WAD, and until this is undertaken, it is not possible to recommend 1 PROM over the other for inclusion in the WAD COS.

Increased GABA+ in People With Migraine, Headache, and Pain Conditions- A Potential Marker of Pain.

Treatment outcomes for migraine and other chronic headache and pain conditions typically demonstrate modest results. A greater understanding of underlying pain mechanisms may better inform treatments and improve outcomes. Increased GABA+ has been identified in recent studies of migraine, however, it is unclear if this is present in other headache, and pain conditions. We primarily investigated GABA+ levels in the posterior cingulate gyrus (PCG) of people with migraine, whiplash-headache and low back pain compared to age- and sex-matched controls, GABA+ levels in the anterior cingulate cortex (ACC) and thalamus formed secondary aims. Using a cross-sectional design, we studied people with migraine, whiplash-headache or low back pain (n = 56) and compared them with a pool of age- and sex-matched controls (n = 22). We used spectral-edited magnetic resonance spectroscopy at 3T (MEGA-PRESS) to determine levels of GABA+ in the PCG, ACC and thalamus. PCG GABA+ levels were significantly higher in people with migraine and low back pain compared with controls (eg, migraine 4.89 IU ± 0.62 vs controls 4.62 IU ± 0.38; P = .02). Higher GABA+ levels in the PCG were not unique to migraine and could reflect a mechanism of chronic pain in general. A better understanding of pain at a neurochemical level informs the development of treatments that target aberrant brain neurochemistry to improve patient outcomes. PERSPECTIVE: This study provides insights into the underlying mechanisms of chronic pain. Higher levels of GABA+ in the PCG may reflect an underlying mechanism of chronic headache and pain conditions. This knowledge may help improve patient outcomes through developing treatments that specifically address this aberrant brain neurochemistry.

The Importance of Perceived Relevance: A Qualitative Evaluation of Patient's Perceptions of Value and Impact Following a Low-Intensity Group-Based Pain Management Program.

Background and objectives: Limited evidence exists exploring perceptions of which aspects of a pain management program are perceived as valuable and impactful. The aim of this study was to explore patient beliefs about which aspects of a pain management program were valued and/or had perceived impact. Materials and Methods: One-on-one structured interviews were conducted with 11 adults three months after their completion of the Spark Pain Program at Westmead Hospital, Sydney, Australia. Concepts in the transcripts were inductively identified and explored, utilizing thematic analysis to better understand their relevance to the study aim. Results: Four themes emerged: (1) "The program overall was positive, but…"; (2) "I valued my improved knowledge and understanding of pain, but…"; (3) "I valued the stretching/relaxation/pacing/activity monitoring"; and (4) "I valued being part of a supportive and understanding group". Participants reported that they liked being treated as an individual within the group. A lack of perceived personal relevance of key messages was identified in some participants; it appears that patients in pain programs must determine that changes in knowledge, beliefs, and attitudes are personally relevant in order for the changes to have a significant impact on them. Conclusions: This study provides new insights into aspects of a pain management program that were perceived as valuable and impactful, areas that "missed the mark", and hypotheses to guide the implementation of service delivery and program redesign.

Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.

STUDY DESIGN: Pilot randomized controlled trial. BACKGROUND: Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. METHODS: Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. RESULTS: Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. CONCLUSIONS: Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. TRIAL REGISTRATION: Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true.

Brain GABA and glutamate levels across pain conditions: A systematic literature review and meta-analysis of 1H-MRS studies using the MRS-Q quality assessment tool.

BACKGROUND: A proposed mechanism of chronic pain is dysregulation between the main inhibitory (GABA) and excitatory (glutamate) neurometabolites of the central nervous system. The level of these neurometabolites appears to differ in individual studies of people with pain compared to pain-free controls across different pain conditions. However, this has yet to be systematically investigated. AIMS: To establish whether GABA, glutamate, glutamine and Glx levels differ across pain conditions when compared to pain-free controls. METHODS: Five databases were searched. Studies were included if they investigated: 1) A pain condition compared to control. 2) Reported GABA, glutamate, glutamine or glutamate/glutamine level. 3) Used 1H-Magnetic Resonance Spectroscopy (Prospero Project ID CRD42018092170). Data extracted included neurometabolite level, pain diagnosis, and spectroscopy parameters. Meta-analyses were conducted to establish the difference in neurometabolite level between participants with pain and pain-free controls for different pain conditions. The MRS-Q was developed from existing clinical consensus to allow for the assessment of quality in the included studies. RESULTS: Thirty-five studies were included investigating combinations of migraine (n = 11), musculoskeletal pain (n = 8), chronic pain syndromes (n = 9) and miscellaneous pain (n = 10). Higher GABA levels were found in participants with migraine compared to controls (Hedge's G 0.499, 95%CI: 0.2 to 0.798). In contrast, GABA levels in musculoskeletal pain conditions (Hedge's G -0.189, 95%CI: 0.530 to 0.153) and chronic pain syndromes (Hedge's G 0.077, 95%CI: 1.612 to 1.459) did not differ from controls. Results for other brain neurometabolites revealed significantly higher levels for glutamate in participants with migraine and Glx in chronic pain syndromes compared to controls. CONCLUSION: These results support the theory that underlying neurometabolite levels may be unique in different pain conditions and therefore representative of biomarkers for specific pain conditions.

Definitions and participant characteristics of frequent recurrent headache types in clinical trials: A systematic review.

Background Clear definitions of study populations in clinical trials may facilitate application of evidence to clinical populations. This review aimed to explore definitions of study populations in clinical trials on migraine, tension-type headache, cluster headache, and cervicogenic headache. Methods We performed a systematic review of clinical trials investigating treatment efficacy for migraine, tension-type headache, cluster headache, and cervicogenic headache. We extracted data on diagnosis, inclusion criteria and baseline headache characteristics. Results Of the 229 studies reviewed, 205 studies (89.5%) defined their populations in adherence to the International Classification of Headache Disorders (ICHD) criteria. Some studies ( n = 127, 55.5%) specified diagnosing through interview, clinical examination and diary entry. The most commonly reported inclusion criteria were pain intensity for migraine and tension-type headache studies ( n = 123, 66.1% and n = 21, 67.7%, respectively), episode frequency ( n = 5, 71.4%) for cluster headache studies, and neck-related pain for cervicogenic headache studies ( n = 3, 60%). Few studies reported details on the extent to which diagnostic criteria were present at baseline. Conclusions ICHD is routinely used in defining populations in headache studies. Details of baseline headache characteristics were not as consistently reported.

Six-month clinical course and factors associated with non-improvement in migraine and non-migraine headaches.

Background Evidence on the medium-term clinical course of recurrent headaches is scarce. This study explored the six-month course and factors associated with non-improvement in migraine compared with tension-type headache and cervicogenic headache. Methods In this longitudinal cohort study, the six-month course of headaches was prospectively examined in participants (n = 37 with migraine; n = 42 with tension-type or cervicogenic headache). Participants underwent physical examination for cervical musculoskeletal impairments at baseline. Participants also completed questionnaires on pain, disability and other self-report measures at baseline and follow-up, and kept an electronic diary for 6 months. Course of headaches was examined using mixed within-between analyses of variance and Markov chain modeling. Multiple factors were evaluated as possible factors associated with non-improvement using regression analysis. Results Headache frequency, intensity, and activity interference in migraine and non-migraine headaches were generally stable over 6 months but showed month-to-month variations. Day-to-day variations were more volatile in the migraine than the non-migraine group, with the highest probability of transitioning from any headache state to no headache (probability = 0.82-0.85). The odds of non-improvement in disability was nearly six times higher with cervical joint dysfunction (odds ratio [95% CI] = 5.58 [1.14-27.42]). Conclusions Headache frequency, intensity, and activity interference change over 6 months, with day-to-day variation being more volatile in migraine than non-migraine headaches. Cervical joint dysfunction appears to be associated with non-improvement for disability in 6 months. These results may contribute to strategies for educating patients to help align their expectations with the nature of their headaches.

The Association Between Clinical Characteristics of Migraine and Brain GABA Levels: An Exploratory Study.

UNLABELLED: Migraine is prevalent and disabling yet is poorly understood. One way to better understand migraine is to examine its clinical characteristics and potential biomarkers such as gamma-aminobutyric acid (GABA). The primary objective of this study was to explore whether relevant disease characteristics of migraine are associated with brain GABA levels. Twenty adults fulfilling the established diagnostic criteria for migraine and 20 age- and gender-matched controls completed this cross-sectional study. Pain, central sensitization, negative emotional state, and perceived disability were measured using Short-form McGill Pain Questionnaire-2, Central Sensitization Inventory, Depression Anxiety Stress Scales-21, and Headache Impact Test-6, respectively. Secondary analysis of brain GABA levels of the same cohort measured using proton magnetic resonance spectroscopy was conducted. The migraine group had significantly higher scores than the control group on pain, central sensitization, and disability. Correlation analyses showed fair positive association between GABA levels and pain and central sensitization scores. No association was found between GABA levels and emotional state and disability. These findings are preliminary evidence supporting the use of questionnaires and GABA levels in characterizing migraine better and broadening the diagnostic process. These findings also strengthen the rationale for the role of GABA in migraine pathophysiology and corroborate the potential of GABA as a migraine biomarker. PERSPECTIVE: Higher pain and central sensitization scores were associated with increased brain GABA levels in individuals with migraine. These findings offer preliminary evidence for the usefulness of measuring pain and central sensitization in migraine and provide some support for the possible role of GABA in migraine pathophysiology and its potential as a diagnostic marker.

Elevated levels of GABA+ in migraine detected using (1) H-MRS.

γ-Aminobutyric acid (GABA) has been implicated in several pain conditions, yet no study has systematically evaluated GABA levels in migraine using (1) H-MRS. The accurate detection, separation and quantification of GABA in individuals with migraine could elucidate the role of this neurotransmitter in migraine pathophysiology. Such information may eventually be useful in the diagnosis and development of more effective treatments for migraine. The aims of this study were therefore to compare the concentration of GABA+ in individuals with migraine with that in asymptomatic individuals, and to determine the diagnostic potential of GABA+ in the classification of those with or without migraine. In this case-control study, GABA+ levels in the brain were determined in 19 participants with migraine and 19 matched controls by (1) H-MRS using Mescher-Garwood point-resolved spectroscopy (MEGA-PRESS) sequence. The diagnostic accuracy of GABA+ for the detection of migraine and the optimal cut-off value were determined by receiver operating characteristic analysis. GABA+ levels were significantly higher (p = 0.002) in those with migraine [median, 1.41 institutional units (IU); interquartile range, 1.31-1.50 IU] than in controls (median, 1.18 IU; interquartile range, 1.12-1.35 IU). The GABA+ concentration appears to have good accuracy for the classification of individuals with or without migraine [area under the curve (95% confidence interval), 0.837 (0.71-0.96); p < 0.001]. The optimal GABA+ cut-off value for migraine was 1.30 IU, with a sensitivity of 84.2%, specificity of 68.4% and positive likelihood ratio of +2.67. The outcomes of this study suggest altered GABA metabolism in migraine. These results add to the scarce evidence on the putative role of GABA in migraine and provide a basis to further explore the causal relationship between GABA+ and the pathophysiology of migraine. This study also demonstrates that GABA+ concentration has good diagnostic accuracy for migraine. These findings offer new research and practice directions for migraine diagnosis.

The clinical utility of pain classification in non-specific arm pain.

Mechanisms-based pain classification has received considerable attention recently for its potential use in clinical decision making. A number of algorithms for pain classification have been proposed. Non-specific arm pain (NSAP) is a poorly defined condition, which could benefit from classification according to pain mechanisms to improve treatment selection. This study used three published classification algorithms (hereafter called NeuPSIG, Smart, Schafer) to investigate the frequency of different pain classifications in NSAP and the clinical utility of these systems in assessing NSAP. Forty people with NSAP underwent a clinical examination and quantitative sensory testing. Findings were used to classify participants according to three classification algorithms. Frequency of pain classification including number unclassified was analysed using descriptive statistics. Inter-rater agreement was analysed using kappa coefficients. NSAP was primarily classified as 'unlikely neuropathic pain' using NeuPSIG criteria, 'peripheral neuropathic pain' using the Smart classification and 'peripheral nerve sensitisation' using the Schafer algorithm. Two of the three algorithms allowed classification of all but one participant; up to 45% of participants (n = 18) were categorised as mixed by the Smart classification. Inter-rater agreement was good for the Schafer algorithm (к = 0.78) and moderate for the Smart classification (к = 0.40). A kappa value was unattainable for the NeuPSIG algorithm but agreement was high. Pain classification was achievable with high inter-rater agreement for two of the three algorithms assessed. The Smart classification may be useful but requires further direction regarding the use of clinical criteria included. The impact of adding a pain classification to clinical assessment on patient outcomes needs to be evaluated.

The clinical significance of immediate symptom responses to manual therapy treatment for neck pain: observational secondary data analysis of a randomized trial.

The objective was to explore aspects of symptom responses to manual therapy treatment for neck pain. An observational secondary data analysis of a randomized trial was conducted. 181 participants seeking care from a physiotherapist or chiropractor for a new episode of neck pain were included. Outcome variables included recovery-time and participant-perceived effect of treatment (GPE) at 3-months. There was a significant reduction of ≥1.4 points (95%CI 1.2-1.5) in pre- and post-treatment pain scores at each occasion of treatment. There was also small but significant increases in pain of ≤0.7 points (95%CI 0.4-1.0) between each treatment session, without regression to the preceding pre-treatment level. The relationships between immediate post-treatment effects and longer-term outcomes were explored using multivariate regression analyses. There was significant univariate association between recovery time and cumulative post-treatment changes in pain from the second, third and fourth (Exp(B) = 1.2) treatment sessions, as well as the presence of post-treatment headache (Exp(B) = 0.7) and other minor adverse symptoms (Exp(B) = 0.6). There was significant univariate association between GPE at 3-months and cumulative pain responses from first (B = 0.2), second (B = 0.3), third (B = 0.3) and fourth (B = 0.4) treatment sessions. The change in pain after session 1 was independently associated with GPE (B = 0.2). There was a consistently significant difference of ≥0.7 points (95%CI 0.43-0.89) in the different methods of reporting pain. Our results showed that manual therapy for neck pain involves a "two-steps forward, one-step back" recovery pattern. Whilst minor adverse events are undesirable, they do not seem to be significantly associated with long-term recovery.

People seeking treatment for a new episode of neck pain typically have rapid improvement in symptoms: an observational study.

QUESTION: What is the clinical course of a new episode of non-specific neck pain in people who are treated with multimodal physical therapies in a primary care setting? DESIGN: Observational study with 3-month follow-up, run in conjunction with a randomised trial. PARTICIPANTS: 181 adults who consulted a physiotherapist or chiropractor for a new episode of nonspecific neck pain. OUTCOME MEASURES: Time to recover from the episode of neck pain, time to recover normal activity, and pain and neck-related disability at three months. Clinical and demographic characteristics were investigated as potential predictors of recovery. RESULTS: Within 3 months, 53% of participants reported complete recovery from the episode of neck pain. On a scale from 0 (none) to 10 (worst), pain improved from 6.1 (SD 2.0) at baseline to 2.5 (SD 2.1) at 2 weeks and to 1.5 (SD 1.8) at 3 months. On a scale from 0 (none) to 50 (worst), disability improved from 15.5 (SD 7.4) at baseline to 5.4 (SD 6.4) at 3 months. Faster recovery was independently associated with better self-rated general health, shorter duration of symptoms, being a smoker, and absence of concomitant upper back pain or headache. Higher disability at 3 months was independently associated with higher disability at baseline, concomitant upper or lower back pain, older age, and previous sick leave for neck pain. CONCLUSION: People who seek physical treatments for a new episode of neck pain in this primary care setting typically have high pain scores that improve rapidly after commencing treatment. Although almost half of those who seek treatment do not recover completely within three months, residual pain and disability in this group is relatively low. Physiotherapists should reassure people with a new episode of neck pain that rapid improvement in symptoms is common, modifying this advice where applicable based on risk factors.

Characteristics of a new episode of neck pain.

We report on the demographic and clinical characteristics of patients seeking manual therapy care for a new episode of non-specific neck pain and report on characteristics associated with higher levels of pain and disability in these patients. Demographic and clinical data were collected from patients who enrolled in a clinical trial of manipulation for neck pain. A profile of these patients was formulated using descriptive statistics. Multivariate linear regression models were used to describe the relationship between patient characteristics and severity of pain and disability. Patients with a new episode of non-specific neck pain reported pain intensity of 6.1 ± 2.0 (mean ± SD) on a 0-10 numerical scale and disability scores of 15.7 ± 7.4 (Neck Disability Index/50). Sixty-three percent had a prior history of neck pain. Concomitant symptoms were highly prevalent including upper limb pain (80%), headache (65%), upper back pain (64%), lower back pain (39%), dizziness (31%) and nausea (23%). There was a strong association between pain intensity and disability (p < 0.01). More severe pain was also associated with not having concomitant back pain (p = 0.01) More severe disability was also associated with poor general health (p < 0.01), nausea (p < 0.01), smoking, (p = 0.02) low SF-12 mental health score (p = 0.02), and shorter duration of symptoms (p = 0.03). Patients with a new episode of neck pain, and deemed suitable for treatment with neck manipulation reported moderately high intensity pain and disability with widespread and frequent concomitant symptoms.

A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain.

UNLABELLED: A randomized controlled trial comparing manipulation with mobilization for recent onset neck pain. OBJECTIVE: To determine whether neck manipulation is more effective for neck pain than mobilization. DESIGN: Randomized controlled trial with blind assessment of outcome. SETTING: Primary care physiotherapy, chiropractic, and osteopathy clinics in Sydney, Australia. PARTICIPANTS: Patients (N=182) with nonspecific neck pain less than 3 months in duration and deemed suitable for treatment with manipulation by the treating practitioner. INTERVENTIONS: Participants were randomly assigned to receive treatment with neck manipulation (n=91) or mobilization (n=91). Patients in both groups received 4 treatments over 2 weeks. MAIN OUTCOME MEASURE: The number of days taken to recover from the episode of neck pain. RESULTS: The median number of days to recovery of pain was 47 in the manipulation group and 43 in the mobilization group. Participants treated with neck manipulation did not experience more rapid recovery than those treated with neck mobilization (hazard ratio=.98; 95% confidence interval, .66-1.46). CONCLUSIONS: Neck manipulation is not appreciably more effective than mobilization. The use of neck manipulation therefore cannot be justified on the basis of superior effectiveness.

Conservative interventions provide short-term relief for non-specific neck pain: a systematic review.

QUESTION: Which interventions for non-specific neck pain are effective in reducing pain or disability? DESIGN: Systematic review with meta-analysis of randomised controlled trials. PARTICIPANTS: Adults with non-specific neck pain. INTERVENTION: All interventions for neck pain that were evaluated in trials with a placebo, minimal- or no-intervention control. OUTCOME MEASURES: Pain and disability outcomes (0-100 scale) at the conclusion of a course of treatment (short term), and in the medium (3 to 9 months) and long (> 9 months) term. RESULTS: 33 trials were identified. The interventions with significant short-term effects on pain were manipulation (MD -22, 95% CI -32 to -11), multimodal intervention (MD -21, 95% CI -34 to -7), specific exercise (MD -12, 95% CI -22 to -2), combination orphenadrine/paracetamol (MD -17, 95% CI -32 to -2), and manual therapy (MD -12, 95% CI -16 to -7). There was a significant short-term effect on disability for acupuncture (MD -8, 95% CI -13 to -2) and manual therapy (MD -6, 95% CI -11 to -2). Treatment with laser therapy resulted in better pain outcomes at medium-term follow-up but not at short-term follow-up. No other intervention demonstrated medium- or long-term effects. CONCLUSION: Some conservative interventions for neck pain are effective in the short term. Few interventions that have been investigated have shown longer term effects that are better than placebo or minimal intervention.

Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial.

BACKGROUND: Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. It is thought however, that neck manipulation provides better results than mobilisation where clinically indicated. There is long standing and vigorous debate both within and between the professions that use neck manipulation as well as the wider scientific community as to whether neck manipulation potentially does more harm than good. The primary aim of this study is to determine whether neck manipulation provides more rapid resolution of an episode of neck pain than mobilisation. METHODS/DESIGN: 182 participants with acute and sub-acute neck pain will be recruited from physiotherapy, chiropractic and osteopathy practices in Sydney, Australia. Participants will be randomly allocated to treatment with either manipulation or mobilisation. Randomisation will occur after the treating practitioner decides that manipulation is an appropriate treatment for the individual participant. Both groups will receive at least 4 treatments over 2 weeks. The primary outcome is number of days taken to recover from the episode of neck pain. Cox regression will be used to compare survival curves for time to recovery for the manipulation and mobilisation treatment groups. DISCUSSION: This paper presents the rationale and design of a randomised controlled trial to compare the effectiveness of neck manipulation and neck mobilisation for acute and subacute neck pain.