The Shoulder HD Pilot Trial: a comparison of exercise interventions for rotator cuff tendinopathy

A 12 week exercise program will be delivered by a registered physiotherapist who has completed training in prescribing exercise for rotator cuff tendinopathy. Participants will attend 7 sessions with their physiotherapist, a minimum of 3 sessions will be face to face. Participants have the option to complete the remaining 4 sessions as face to face appointments or via telehealth if they prefer. Participants will be randomised into two different exercise programs. Both groups will complete the same 3 shoulder exercises (shoulder press, lateral shoulder raise, bent over row). One group will complete high load-volume exercise and the other group will complete low load-volume exercise (see next section). Based on evidence from previous trials, including 2 large randomised trials published in 2021 (GRASP and SEXSI trials), it is unclear if one exercise program is superior to the other. Arm 1 - High load-volume: This group will complete three shoulder strengthening exercises (1. Shoulder press, 2. Lateral shoulder raise, 3. Bent over row) with progression over time, three times per week over 12 weeks. In total participants will complete 36 sessions with 7 of these sessions being supervised by their treating physiotherapist as above. The rest of the sessions will be completed by the patient independently at home. Exercise sessions are expected to take approximately 20-30 minutes at most. The intensity (load) will be progressed over time in order to target the desired level of work based on an auto-regulatory approach (repetitions in reserve). The target repetitions in reserve starts at 3-5 and progresses to 1-2 by the final weeks. Participants will use dumbbell weights as resistance in order to meet the intended intensity, reps in reserve target. The number of sets and repetitions begins at 3 sets of 8 and progresses to 5 sets of 4 by week 12. The total volume (sets x reps) is 858 over the 12 weeks. Participants will be advised to take 2-3 minutes rest between sets. The treating physiotherapist will progress and regress the exercises in accordance with the patients level of pain, discomfort and level of fatigue. Participants and when supervised the treating physiotherapist will progress or regress the intensity (load) in order to achieve the target repetition in reserve for that session. Information relevant to both the intervention and control groups Education Participants in both groups will receive education material based upon current evidence and guidelines in order to help them understand their shoulder pain and how to best manage it. This education material has been developed for this trial and has been updated from education materials previously used by our research group. The material will be available electronically and if preferred a printed version will be supplied. Education material will be delivered via their treating physiotherapist and outlines the shoulder joint anatomy, the usual presenting symptoms of rotator cuff tendinopathy, the causes and contributing factors, how rotator cuff tendinopathy is diagnosed, whether a scan is necessary, the recommended guideline based treatments, the potential benefits and harms for treatments including surgery and exercise, guidelines for pain and exercise and how long it usually takes for rotator cuff tendinopathy to improve. Intervention fidelity will be checked for each treating practitioner (minimum of one session) via audio or video recording. Participants progress will be monitored via fortnightly pain questionnaire throughout the duration of the 12 week program and using functional questionnaires at 6, 12 and 26 weeks from the commencement of the intervention. Participants will also complete measurements for strength at baseline pre intervention commencement and again at 6, 12 and 26 weeks post intervention commencement. Exercise adherence: Participants will record their completed exercise via an online form / exercise diary. Participants will be asked to wear an IMU activity tracking sensor on the wrist of their affected shoulder for as much of the 12 week intervention program as able. Data collected from this sensor will be analysed to determine velocity of movement, number of sets and repetitions for each exercise and general physical activity / sleep. Details of the exercise program for both groups: 1. Administered by a registered physiotherapist who has completed training in exercise for rotator cuff tendinopathy 2. Exercise will be delivered via face to face sessions, with the option of several telehealth sessions if preferred (total 7 sessions with a minimum of 3 face to face). Education material will be provided in written format (paper or electronic) and will be reviewed by the treating physiotherapist during the treatment sessions. 3. Participants will attend 7 supervised physiotherapy sessions over 12 weeks. They will complete the remaining sessions at home independently. 4. Both groups will be advised to continue with their exercise program throughout the 12 week intervention if they have pain which they consider acceptable, manageable or bearable. They will be advised that some pain post exercise is considered normal, provided that it has returned to their normal baseline level within 24 hours. If participants experience progressing or worsening pain that become unbearable (>5/10) during their exercises they will be advised to reduce the range of movement, reduce the load or intensity if applicable or to modify the exercises. All materials will be provided to the participants via electronic written form unless they prefer a paper / print version which will be made available if required. Participants will record the number of completed sets and repetitions in an online exercise diary web form, which will also be made available in a paper version if a participant prefers. Physiotherapists delivering the treatment will not deliver the exercise program to both groups. They will be restricted in delivering the exercise program to either the intervention group or the control group but not both.