PhD defense: Daniel Major
On the 2nd of June Daniel Høgli Major defended his thesis "Self-managed exercises for patients with shoulder pain: Components to address in a trial" for the PhD in Health Sciences at Oslo Metropolitan University.
Summary of his work:
Background and aims: Shoulder pain is the third most frequent musculoskeletal disorder, with considerable associated disability and societal costs. Subacromial pain is by far the most common shoulder diagnosis, accounting for up to 70% of cases. Exercise interventions are the first-choice treatment option, according to current clinical guidelines. Recent research findings indicate that self-managed exercise interventions for patients with shoulder pain yield similar clinical effect and superior cost-effectiveness compared to supervised exercise interventions. However, there is limited knowledge on which crucial components are important to address when providing self-managed exercises. The overall aim of this thesis was to assess components of providing a self-managed exercise intervention for patients with shoulder pain, and use the insights gained to plan a future clinical randomized controlled trial. The specific objectives were 1) to assess completeness of content reporting of exercise interventions in randomized controlled trials for patients with shoulder pain, and assess the inter-rater reliability when applying the Consensus and Exercise Reporting Template (CERT), 2) to investigate the relationship between two psychological prognostic factors - fear of movement and emotional distress – and self-reported disability during 1-year of follow-up among patients with shoulder pain, and 3) to assess the feasibility of providing an individualized self-managed exercise intervention (the Ad-Shoulder intervention) in a future clinical trial for patients with shoulder pain.
Methods: Five independent pairs of reviewers applied the CERT tool on 34 exercise trials included in the most recent Cochrane review from 2016 evaluating the effect of manual therapy and exercise for patients with shoulder pain (rotator cuff disease) (Paper I). The CERT score ranged from 0 to 19 with higher scores indicating better reporting. Percentage agreement and the Prevalence and Bias Adjusted Kappa (PABAK) coefficient was used to measure inter-rater reliability between the five pairs of reviewers. In a prospective cohort study (Paper II), consecutive patients with shoulder pain, referred to a secondary outpatient clinic, were included. The association between fear of movement and emotional distress, and patient reported disability measured using QuickDASH over one year of follow-up was analyzed by linear mixed-effects models (LMM) for repeated measures (3 months and 1 year), adjusting for standard covariates and established prognostic factors. A feasibility study (Paper III), based on a pre-post design, recruited participants aged > 18 years, with subacromial pain, who had received conservative treatment during the past six months. The self-managed Ad-Shoulder intervention consisted of 1-5 individual sessions provided over 3 months and was based on 5 self-management skills, which aimed to enhance the patients’ self-efficacy to manage their shoulder pain as well as increase adherence to self-managed exercises. Feasibility outcomes were recruitment rate, follow-up rate, objective physical activity measures by accelerometer (AX3), adherence with the self-managed exercises, fidelity of the delivery of the intervention, and adverse events. The results were reported using descriptive statistics.
Results: In the content reporting study we found a median CERT score of 5 (range 0-16). Percentage agreement between the five independent pairs of reviewers was high for 15 items and acceptable for 4 items. The PABAK coefficient indicated excellent inter-rater agreement for 5 items, substantial for 11 items, and moderate for 3 items, respectively. A total of 138 patients with shoulder pain, recruited between March 2015 and January 2018, were included in the prospective cohort study, and 117 and 110 provided follow-up data at 3 months and one year respectively. Adjusted associations revealed that for every point increase in baseline fear of movement, the QuickDASH score increased (worsened) by 1.10 points (95% CI 0.2-2.0) over the year of follow-up. For baseline emotional distress the QuickDASH score increased by 19.9 points (95% CI 13.9-25.9) over the follow-up year. Eleven participants with subacromial pain were recruited during 16 weeks to the feasibility study. Ten out of 11 participants completed the self-reported measures at baseline and Week 12. All sessions were delivered according to the protocol. Accelerometer measures were successfully obtained for 100% (11/11) at baseline, 64% (7/11) at week six and 82% (9/11) at week 12. Six of the 11 participants (55%) satisfactorily completed at least 80% of their home exercise program. None of the participants reported any adverse events.
Conclusions: Three studies on important components to address in a future trial evaluating the effectiveness of a self-managed exercise intervention for patients with shoulder pain showed that 1) the quality of the content reporting of exercise interventions for patients with shoulder pain in published trials was poor, and can be enhanced by using a standardized checklist for exercise reporting (e.g. CERT); 2) fear of movement and emotional distress significantly impacted self-reported disability during the year of follow-up in patients with shoulder pain, and should be targeted when delivering an individualized self-managed exercise intervention; and 3) the Ad-Shoulder intervention met the pre-specified progression criteria for accelerometer measurements, the physiotherapists’ fidelity to the intervention, and adverse events, but not the criteria for recruitment and adherence to the self-managed exercise program. Therefore, in a future trial adherence to self-managed exercises needs to be closely monitored and facilitated during the intervention period. Overall/added together, the findings of this thesis have expanded the knowledge about crucial components to address when delivering an individualized self-managed exercise intervention like the Ad-Shoulder intervention for patients with shoulder pain and have also provided insights that can be used in a future trial on the effectiveness of the AdShoulder intervention.