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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-100
SponsorKing Faisal Specialist Hospital & Research Center

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

Qualifiers

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

Treatments tested in this trial

  • Group A
  • Therapeutic exercises, education and advice
  • Group B (Control Group)

Treatment groups

86 Participants
are divided into 2 treatment groups