About this trial
Background Rotator cuff tears (RCTs) are a common, costly, and often persistent musculoskeletal complaint, with an increasing number of shoulder pain patients undergoing surgical repair each year. Whereas many asymptomatic RCTs can be successfully managed non-surgically, when conservative treatment fails, surgery is recommended. However, there is a lack of consensus on the best approach to postoperative rehabilitation, an important factor in the recovery process of rotator cuff repairs. This study aims to investigate the effectiveness of early versus delayed rehabilitation following rotator cuff repairs.
Objective This study aims to determine the effectiveness of early versus delayed rehabilitation following rotator cuff repairs.
Method A two-armed, randomized controlled trial will be conducted in an outpatient physical rehabilitation department at a tertiary hospital. The sample will include 88 adults aged 18 years or older with RCTs. From the day after surgery, the intervention will engage in supervised passive range of motion (ROM) exercises, focusing on forward flexion and external rotation. They will receive daily exercise instructions, including table slides and active movements for the elbow, wrist, and hand, while also practicing passive shoulder flexion and abduction based on their pain limits. Participants are encouraged to do gentle pendulum exercises and passive movements three times daily to improve shoulder mobility. Active shoulder exercises will be restricted until six weeks post-surgery to ensure healing. Sling use will decrease by the sixth week, allowing for active ROM exercises to start. Participants in the control group will follow a delayed rehabilitation protocol, learning strict sling immobilization techniques for the first six weeks postoperatively. During this period, sling removal will be allowed only for basic exercises and daily activities, with no other shoulder movements encouraged initially. Sling use will end by the sixth week, followed by the start of active ROM exercises.
Outcome measures will include shoulder ROM, muscle power, a numeric pain scale (NPS), shoulder pain disability index (SPADI), and EQ-5D-5L questionnaires assessed at 3, 6, and 12 months follow-up between the two groups. Rotator cuff integrity will be evaluated using MRI at baseline and at 12 months post-surgery.
Conclusion We anticipate that this study will add to the body of knowledge required to make effective treatment choices on the management of patients following rotator cuff repairs. Ultimately, this trial aims not only to influence national rehabilitation guidelines but also to enrich the global evidence base concerning optimal rehabilitation strategies following rotator cuff repair, especially for populations in the Middle East and Gulf regions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
Patients diagnosed with a symptomatic tear of the rotator cuff and listed for surgical repair
Rotator cuff tear confirmed by MRI
Patients screened by the surgeon as suitable to participate
Disqualifiers
Individuals younger than 18 years
Those unable or unwilling to consent or continue with the study.
Moderate to severe arthritis seen on x rays or MRI
Fatty infiltration grade >= 3
Trial design
Parallel
Treatments tested in this trial
Group A
Other interventionFrom postoperative Day 1, participants will perform passive range of motion (ROM) exercises twice daily under the guidance of a physical therapist, focusing on forward flexion and external rotation. They will also receive instructions to perform specific daily exercises, including table slides, active elbow, wrist, and hand movements, and passive shoulder flexion and abduction-all within the limits of pain. Outside of these structured sessions, gentle pendulum exercises and additional passive movements (including abduction, flexion, and external rotation to 30 degrees) will be recommended three times daily to promote ROM and shoulder mobility. Active shoulder exercises will be restricted until postoperative week 6. Sling use will be gradually discontinued by week 6, at which point active-assisted ROM will be introduced. Full active ROM will be targeted by week 12, followed by progression to strengthening exercise.
Therapeutic exercises, education and advice
Other interventionIntervention will be provided with passive exercises and education from day one after surgery.
Group B (Control Group)
Other interventionParticipants in the control group will follow a delayed rehabilitation protocol, learning strict sling immobilization techniques for the first six weeks postoperatively. During this period, sling removal will be allowed only for basic exercises and daily activities, with no other shoulder movements encouraged initially. Sling use will end by the sixth week, followed by the start of active ROM exercises.
Treatment groups
Trial outcomes
Primary outcomes
Shoulder pain and disability score
The Shoulder Pain and Disability Index (SPADI) will be used to evaluate potential participants' shoulder pain and function. This self-report questionnaire assesses pain and disability related to musculoskeletal shoulder issues \[39\]. SPADI consists of 13 items divided into two domains: pain (5 questions) and disability (8 questions), scored from zero (no pain or difficulty) to ten (worst pain or difficulties needing assistance). Each domain equally contributes to an overall percentage score, with zero indicating no issues and 100% indicating maximum pain and disability. It will be measured by a trained, experienced and quality physical therapist at baseline, 3, 6 and 12 months.
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