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A novel evidence-based group exercise and education intervention for rotator cuff related shoulder pain: a pilot randomised controlled trial

A novel evidence-based group exercise and education intervention for adults with rotator cuff related shoulder pain: a pilot randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000308594
Enrollment
32
Registered
2024-03-22
Start date
2024-05-10
Completion date
2024-07-17
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Clinical guidelines recommend 6-12 weeks of conservative care for first presentation of rotator cuff related shoulder pain prior to considering imaging or surgery. In contrast, surveys of practitioners conducted by our group identified high rates of inappropriate imaging (up to 82%), inadequate education and highly variable exercise interventions and timeframes. High-quality group interventions for RCRSP have the potential to improve quality of care, patient adherence and clinical outcomes and economic outcomes for this condition. This pilot feasibility and randomised controlled trial will compare a 12-week group exercise and education intervention to i) active control (education only), and ii) usual care.

Interventions

Group exercise and education Participants randomised to the group exercise/education group will attend six fortnightly 60-minute group exercise/education sessions over 12 weeks at a single physiotherapy clinic. Participants will complete a total of three exercise sessions per week, including the 6 supervised sessions, with the remaining sessions to be completed independently at home. Prior to commencing the group exercise sessions, a single session of education (30 minutes) will be provided v

Group exercise and education Participants randomised to the group exercise/education group will attend six fortnightly 60-minute group exercise/education sessions over 12 weeks at a single physiotherapy clinic. Participants will complete a total of three exercise sessions per week, including the 6 supervised sessions, with the remaining sessions to be completed independently at home. Prior to commencing the group exercise sessions, a single session of education (30 minutes) will be provided via a pre-recorded video sent to participants. The education session will include education regarding i) shoulder anatomy and causes of RCRSP and rotator cuff tendinopathy, ii) tissue changes are a normal part of healthy ageing, iii) factors that may worsen, or improve, shoulder pain and function, iv) monitoring pain during exercise and how much pain is acceptable, v) activity modification during activities of daily living and exercise, vi) prognosis, and vii) general physical activity recommendations. Prior to commencing group exercise classes, participants will attend a teleconference (Zoom) session where they will have an opportunity to ask questions. The video and teleconference session will be provided by a physiotherapist. Exercise fidelity will be assessed by audio recording sessions. There will be a maximum of four participants in each group. Group exercise will be supervised the same physiotherapist. The exercise program will be progressive and consist of shoulder exercises focusing on elevation, external rotation, pushing and pulling, using body weight, hand weights and resistance bands. Shoulder exercise will comprise of three sets of 15 repetitions and four seconds per cycle for isotonic exercise (two second concentric and two second eccentric phase) or six sets of 30 seconds if isometric exercise is commenced initially. Participants will progress through pre-determined levels of difficulty based on achieving the prescribed dosage (sets, repetitions, time under tension). Exercise difficulty and load will be progressed, or regressed, so that fatigue is achieved after the prescribed number of repetitions. The physiotherapist providing care will receive training from researchers (1 x 1.5 hour training session on site) in how to prescribe and monitor the exercises in a standardised way prior to the study commencing. Adherence to home-based exercise will be monitored with an exercise diary, completed by participants.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be included if the following criteria are satisfied: (i) 18 years of age or older; (ii) primary complaint of anterolateral shoulder pain (with or without referral into the arm) for eight or more weeks; (iii) preserved passive shoulder range; (iv) shoulder pain related to movement or resisted muscle contraction (e.g. empty/full can tests).

Exclusion criteria

Participants with any of the following conditions will be excluded: (i) massive rotator cuff tendon tear of two or more tendons (based on clinical presentation or imaging if available); (ii) gross shoulder instability; (iii) significant shoulder trauma (e.g. previous fracture); (iv) previous shoulder surgery; (v) shoulder osteoarthritis (glenohumeral or acromioclavicular); (vi) hemiplegic shoulder; (vii) a complex myofascial neck/shoulder/arm pain condition; (viii) suspected cervical spine referred pain; or (ix) a systemic inflammatory condition (e.g. rheumatoid arthritis).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026