Internet and Telerehabilitation-Delivered Management of Rotator Cuff–Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial

Abstract

Background Rotator cuff–related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes. Objective The primary aim of this pilot randomized 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 Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively. Results We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in 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), with the exception of one instance of elective surgery (unrelated to the person’s shoulder condition). Conclusions Our prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5

The Utilization and Benefits of Telehealth Services by Health Care Professionals Managing Breast Cancer Patients during the COVID-19 Pandemic

“…Telerehabilitation provides reasonable medical care access to individuals in the comfort of their homes or other living environments, increases the reach of physicians and reduces the need for face-to-face rehabilitation particularly where there are limited personnel and financial resources [82]. Internet-based provision of telerehabilitation services may increase access and allows the rehabilitation therapist or clinician to optimize and tailor treatment in a personalized manner with resulting improved adherence and outcome [83].…”

Zelen design clinical trials: why, when, and how

“…Over the last 10 years, Zelen designs have been employed to evaluate a range of outreach and care navigation interventions to promote treatment engagement, including postcard or electronic messaging outreach to prevent suicide attempts or self-harm [ 14 , 15 ], eHealth intervention to increase engagement in eating disorder treatment [ 16 ], care navigation to promote advanced care planning in older adults [ 17 ], and assessment plus feedback to improve early adherence to substance use treatment [ 18 ]. Similarly, this design has been used to evaluate health promotion or behavior change interventions, including a text message for HIV prevention [ 19 ], rehabilitation interventions for musculoskeletal conditions [ 20 – 22 ], health coaching to improve chronic illness management [ 23 ], and oral health intervention to prevent early childhood caries [ 24 ]. Zelen designs have also been employed to evaluate programs to prevent re-hospitalization [ 25 ] or reduce frequent emergency department use [ 26 ].…”

The Utilization and Benefits of Telehealth Services by Health Care Professionals Managing Breast Cancer Patients During the COVID-19 Pandemic

“…Telerehabilitation provides reasonable access of medical care to individuals in the comfort of their homes or other living environments, increase the reach of physicians and reduce the need for face-to-face rehabilitation particularly where there are limited personnel and financial resources [79). Internet-based provision of telelerehabilitation services may increase access and allows the rehabilitation therapist or clinician to optimize and tailor treatment in a personalized manner with resulting improved adherence and outcome [80].…”