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

NCT07324174 | Not Yet Recruiting DMC

• 1 other identifier: IRB#2251676
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rotator cuff tear, post rotator cuff repair, physical rehabilitation, early rehabilitation, delayed rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of study at 12 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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.

Other: Group B (Control Group)

Intervention arm

EXPERIMENTAL

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.

Other: Group A; Other: Therapeutic exercises, education and advice

Interventions

Group A OTHER

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.

Also known as: Therapeutic exercises, Education and advice

Intervention arm

Therapeutic exercises, education and advice OTHER

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

Intervention arm

Group B (Control Group) OTHER

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.

Also known as: Education and Advice

Control arm

Eligibility Criteria

• Age: 17 Years - 100 Years
• Gender Eligibility Details: Male and female genders
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to attend out-patient follow-up physiotherapy appointment
• Demonstrate the ability and willingness to consent and continue participation in the study
• Able to understand Arabic or English Language

You may not qualify if:

• A patient will not be eligible for participation in the study if any of the following criteria apply:
• 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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (27)

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MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise Therapy; Educational Status; Counseling; Control Groups

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

COLLINS OGBEIVOR, PhD, MSc, BMR-Physio

CONTACT

+966504439043; cogbeivor@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Consultant Physical Rehabilitation

Model Details: From the day after surgery, participants in the intervention group will engage in supervised passive range of motion (ROM) exercises focusing on forward flexion and external rotation. They will receive daily instructions for table slides and active movements for the elbow, wrist, and hand, while practicing passive shoulder flexion and abduction within their pain limits. Gentle pendulum exercises and passive movements are encouraged three times daily to improve shoulder mobility. Active shoulder exercises will be restricted until six weeks post-surgery to ensure proper healing. Sling use will gradually decrease by the sixth week, allowing active ROM exercises to begin. The control group will follow a delayed rehabilitation protocol with strict sling immobilization for the first six weeks, only allowing sling removal for basic exercises and activities. After six weeks, they will also start active ROM exercises.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)