A Randomized Controlled Trial on the Effectiveness of Early Versus Conservative Rehabilitation Following Rotator Cuff Repair

Summary

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.

Conditions

• Rotator Cuff Tear

Interventions

OTHER

Group A

From 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.

OTHER

Therapeutic exercises, education and advice

Intervention will be provided with passive exercises and education from day one after surgery.

OTHER

Group B (Control Group)

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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2029-12-30

Completion

2029-12-30

Countries

• Saudi Arabia

Study Locations