JMIR Publications

ABSTRACT

Background:

Rotator cuff related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based delivery of recommended care may improve access to care but risks high rates of non-adherence and attrition. Supplementing internet delivered care with group-based telerehabilitation may improve adherence and outcomes.

Objective:

The primary aim of this pilot randomised controlled trial was to assess the feasibility of a 12-week internet delivered intervention for RCRSP comparing advice only, recommended care and recommended care with group-based telerehabilitation.

Methods:

Reporting was in accordance with the CONSORT checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for ≥3 months were identified via a paid Facebook strategy. Screening involved; 1) an online questionnaire excluding participants with symptoms not consistent with RCRSP; 2) confirmation of the diagnosis via a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) into one of the three groups: ‘Advice only’ included education about risk factors and activity modification, the ‘recommended care’ group included evidence-based, internet delivered education and exercise three times per week, and the ‘recommended care and telerehabilitation’ group also included a weekly group (three participants) teleconference session. Progression to full-scale trial was based on the following primary feasibility outcome criteria; (i) recruitment of ≥20% of eligible participants; (ii) acceptable adherence (at least two of the three prescribed weekly sessions completed) among ≥70% of participants; (iii) ≥80% retention; (iv) absence of intervention-related serious adverse events; and (v) ≥80% response rates to questionnaires. Secondary clinical, economic and patient knowledge outcomes were collected (success criterion ≥80%) at baseline, six and 12 weeks (for clinical and patient knowledge), baseline, four, eight and twelve weeks for economic outcomes. Descriptive data for clinical outcomes were reported at each timepoint as well as within group effect sizes (baseline to six and 12 weeks).

Results:

Twelve participants were allocated to each of the three trial arms (mean age between 51 and 56, 83% to 92% female). We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a three-week period. Retention at the 12-week endpoint was 94% and response to email questionnaires at other timepoints was ≥83%. We found acceptable adherence (defined as >70% performing exercise two or three times/week) in the recommended care group with telerehabilitation but not the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms) aside from one instance of elective surgery (unrelated to the person’s shoulder condition).

Conclusions:

Our pre-specified success criteria were met or exceeded but there was a gender imbalance towards women. It is feasible to progress to a fully powered trial but strategies to address the gender imbalance need to be implemented. Clinical Trial: Australian New Zealand Clinical Trials Registry (ACTRN12620000248965)