Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial)

Abstract

ObjectivesThe aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain.DesignTwo-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial.MethodsTwenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups—tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.ResultsThe recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping.ConclusionsOur feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial.Trial registration numberANZCTR: 12617001405303.

Test-retest reliability of movement-evoked pain and sensitivity to movement-evoked pain in patients with rotator cuff-related shoulder pain

“… 26 Participants were invited to attend an in-person screening session if they were aged 18–75 years old, 27 and reported having shoulder pain. During this initial screening, participants were excluded if they reported a history of shoulder or cervical surgery in the past six months, 6 , 28 corticosteroid injection in the last six weeks, 27 history of shoulder subluxation or dislocation, systemic inflammation or disease, neurological disease affecting the shoulder, or tumor. 29 …”

“…Movement-evoked pain can be defined as pain experienced during movement in a specific context. 4 , 5 Movement-evoked pain is typically more severe than pain at rest in patients with rotator cuff-related shoulder pain (RCRSP), 6 which is the most common diagnosis of shoulder pain, 7 , 8 , 9 and seems to be mediated by peripheral and central sensitization mechanisms and psychological factors. 3 , 4 , 10 , 11 , 12 Repetitive movement tasks are recommended for movement-evoked pain assessment.…”

Clinicians’ perspectives on planned interventions tested in the Otago MASTER feasibility trial: an implementation-based process evaluation study

“…8 This study reports a process evaluation of the Otago MASTER feasibility trial. This mixed-methods, process evaluation study aimed to investigate: (1) supervised treatment fidelity of the interventions and (2) clinicians' perceptions of the trial interventions through a focus group.…”

“…This paper expands the analysis that was conducted and reported in the MAnagement of Subacromial disorders of The shouldER (MASTER) feasibility trial. 1 The Otago MASTER trial recruited 28 Physiotherapy interventions (eg, exercise, manual therapy, advice and education) are considered as the first line of treatment with patients who have shoulder pain. 2 There is limited evidence supporting exercise therapy as an effective intervention for improving pain and function in patients with shoulder pain.…”

“…This paper expands the analysis that was conducted and reported in the MAnagement of Subacromial disorders of The shouldER (MASTER) feasibility trial. 1 The Otago MASTER trial recruited 28 participants and allocated them into one of the following interventions: tailored exercise and manual therapy or standardised exercise interventions. A total of five clinicians delivered the interventions.…”