Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial).

INTRODUCTION: Musculoskeletal (MSK) conditions constitute the highest burden of disease globally, with healthcare services often utilised inappropriately and overburdened. The aim of this trial is to evaluate the effectiveness of a novel clinical PAthway of CarE programme (PACE programme), where care is provided based on people's risk of poor outcome. METHODS AND ANALYSIS: Multicentre randomised controlled trial. 716 people with MSK conditions (low back pain, neck pain or knee osteoarthritis) will be recruited in primary care. They will be stratified for risk of a poor outcome (low risk/high risk) using the Short Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMSPQ) then randomised to usual care (n=358) or the PACE programme (n=358). Participants at low risk in the PACE programme will receive up to 3 sessions of guideline based care from their primary healthcare professional (HCP) supported by a custom designed website (mypainhub.com). Those at high risk will be referred to an allied health MSK specialist who will conduct a comprehensive patient-centred assessment then liaise with the primary HCP to determine further care. Primary outcome (SF 12-item PCS) and secondary outcomes (eg, pain self-efficacy, psychological health) will be collected at baseline, 3, 6 and 12 months. Cost-effectiveness will be measured as cost per quality-adjusted life-year gained. Health economic analysis will include direct and indirect costs. Analyses will be conducted on an intention-to-treat basis. Primary and secondary outcomes will be analysed independently, using generalised linear models. Qualitative and mixed-methods studies embedded within the trial will evaluate patient experience, health professional practice and interprofessional collaboration. ETHICS AND DISSEMINATION: Ethics approval has been received from the following Human Research Ethics Committees: The University of Sydney (2018/926), The University of Queensland (2019000700/2018/926), University of Melbourne (1954239), Curtin University (HRE2019-0263) and Northern Sydney Local Health District (2019/ETH03632). Dissemination of findings will occur via peer-reviewed publications, conference presentations and social media. TRIAL REGISTRATION NUMBER: ACTRN12619000871145.

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).

Magnetic resonance imaging findings of fatty infiltrate in the cervical flexors in chronic whiplash.

STUDY DESIGN: Retrospective investigation of muscle changes in patients suffering from chronic whiplash-associated disorders (WAD). OBJECTIVES: To quantitatively compare the presence of muscle alterations (fatty infiltrate [MFI] and cross-sectional area [CSA]) in the anterior musculature of the cervical spine in a cohort of chronic whiplash patients (WAD II) and healthy control subjects across muscle and cervical segmental level. SUMMARY OF BACKGROUND DATA: Magnetic resonance imaging can be regarded as the gold standard for muscle imaging. There is little knowledge about in vivo features of anterior neck muscles in patients suffering from chronic WAD and how muscle structure differs across the factors of muscle, vertebral level, age, self-reported pain and disability, body mass index, and duration of symptoms. METHODS: Reliable magnetic resonance imaging measures for MFI and CSA were performed for the anterior cervical muscles bilaterally in 109 female subjects (78 WAD, 31 healthy control; 18-45 years, 3 months to 3 years postinjury). The measures were performed on all subjects for the longus capitis and colli and the sternocleidomastoid muscles. RESULTS: The WAD subjects had significantly larger MFI and CSA for the anterior muscles compared to healthy control subjects (all P < 0.0001). In addition, the amount of MFI varied by both cervical level and muscle, with the longus capitis/colli having the largest amount of fatty infiltrates at the C2-C3 level (P < 0.0001). MFI was inversely related to age, self-reported pain/disability, and body mass index but directly proportional to duration of symptoms. CONCLUSION: There is significantly greater MFI and CSA in the anterior neck muscles, especially in the deeper longus capitis/colli muscles, in subjects with chronic WAD when compared to healthy controls. Future studies are required to investigate the relationships between muscular morphometry and symptoms in patients suffering from acute and chronic WAD.