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

January 7, 2026 updated by: Collins Ogbeivor, King Faisal Specialist Hospital & Research Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Shoulder pain affects one in three people at some point in their lives (Chester et al., 2013; van der Heijden, 1999). It is one of the most common musculoskeletal conditions, with an estimated lifetime prevalence of up to 70% (Cadogan et al., 2011; Carr et al., 2015). The leading cause of shoulder pain and disability is rotator cuff tears (RCTs) (Largacha et al., 2006; Flatow et al., 1994). RCTs are a frequent and costly problem that often results in persistent pain, with more patients choosing surgical repair each year (Sealey and Lewis, 2016). Many asymptomatic RCTs can be effectively managed non-surgically through physiotherapy-led exercises, pain medications, or cortisone injections. However, when conservative treatments fail, surgical intervention may be recommended. While both surgical and non-operative treatments have their risks and benefits, a significant percentage of individuals have asymptomatic RCTs. Over time, many of these patients are at risk of developing symptoms of pain and disability (Tashjian, 2012).

Using high-resolution sonography, Yamaguchi et al. (2001) studied 58 patients with unilateral symptomatic full-thickness RCTs alongside a contralateral asymptomatic tear. They found that 51% of the previously asymptomatic tears developed pain symptoms and showed reduced shoulder function over a mean follow-up period of 2.8 years. Additionally, 50% of the newly symptomatic tears increased in size, while only 20% of the asymptomatic tears progressed. This study indicates that if RCTs are left unrepaired, they have limited capacity for self-healing. More importantly, it suggests a significant risk of tear progression, which correlates with increased shoulder pain and loss of function. Furthermore, Mall et al. (2010) conducted a prospective study involving a cohort of 195 patients diagnosed with asymptomatic RCT (RCTs). This study examined the progression of pain, shoulder function, and tear size over time. The researchers compared 44 patients who developed symptoms to a matched group of 45 who remained asymptomatic. The findings revealed that individuals with asymptomatic RCTs who became symptomatic experienced a substantial decline in shoulder function and an increase in tear size, showing a 23% increase compared to only 4% for those who remained asymptomatic, approximately two years after the initial evaluation (P < 0.1) Previous studies (Maman et al., 2009; Safran et al., 2011) have indicated that patients with symptomatic full-thickness tears who undergo conservative treatment face a significant risk of experiencing an additional 50% tear within two years. Consequently, early surgical intervention is advised for young adults (aged 65 and younger) with significant (> 1-1.5 cm) reparable full-thickness tears, provided they do not exhibit chronic muscle changes, due to the increased likelihood of developing a larger tear over time (Tashjian, 2012). Additionally, surgical repair is recommended for acute RCT across all age groups, except for those with small (< 1-1.5 cm) full-thickness tears. This recommendation is based on the substantial risks of irreversible changes associated with conservative treatment and the high probability of healing when repair is performed promptly (Mantone et al., 2000). For instance, Petersen and Murphy (2011) suggest that substantial (> 1-1.5 cm) acute full-thickness tears should ideally be repaired within three weeks of the injury to maximize the restoration of shoulder function.

Clinical studies (Weber, 1999; Kartus et al., 2006) evaluating patients with partial-thickness and full-thickness RCTs have shown that those treated with arthroscopic debridement and acromioplasty, without tendon repair, exhibited limited spontaneous healing of the rotator cuff. Prospective longitudinal studies indicate that the long-term clinical outcomes for both arthroscopic and open rotator cuff repairs are favorable, with over 90% of patients reporting good or excellent results at a 10-year follow-up (Galatz et al., 2001; Wolf et al., 2004). However, the effectiveness of these surgical interventions can vary depending on factors such as the patient's age, the extent of the tear, and the presence of any comorbid conditions.

Further research is needed to identify optimal treatment strategies that can enhance healing and improve functional outcomes for patients with RCTs following surgery. Additionally, exploring the role of rehabilitation protocols and postoperative care may provide valuable insights into maximizing recovery and minimizing the risk of re-tears. In practice, most post-surgical rehabilitation protocols for RCT repairs focus on protecting the repaired tissue, strengthening the rotator cuff and scapulothoracic muscles, and improving shoulder range of motion [ROM] (Corban et al., 2024). However, there remains a debate regarding the most effective rehabilitation protocol for post-surgery RCT patients.

Rehabilitation typically takes between 4 and 12 months, with patients often immobilized in a sling for 4 to 6 weeks after surgery (Sheps et al., 2018). Nevertheless, there is conflicting evidence regarding the optimal duration of postoperative immobilization (Chang et al., 2015; Chan et al., 2014). Some authors suggest that early mobilization may reduce patient burden and the occurrence of postoperative shoulder stiffness and muscle atrophy but may also increase the risk of re-tears (Chang et al., 2015; Papalia et al., 2012; Denard et al., 2011). Tirefort et al. (2019), in a well-designed randomized controlled trial, compared clinical and radiographic outcomes for up to 6 months post-rotator cuff repair with and without postoperative sling immobilization in a cohort of 80 patients with isolated full-thickness superior small to medium-sized RCTs. The study found that patients who did not use a sling had better outcomes, including reduced shoulder pain, improved mobility, and higher functional scores, compared to those who underwent sling immobilization at the 3 and 6-month follow-ups. However, due to the small sample size of the participants, the findings of this study should be interpreted cautiously. A systematic review conducted by Mazuquin and colleagues (2018) examined the effectiveness of early rehabilitation compared to conservative rehabilitation for patients who underwent postoperative repair of rotator cuff tears (RCTs). The study found no significant differences in shoulder function, pain levels, ROM (ROM), or rates of retears between the two approaches. Nonetheless, the authors concluded that early mobilization might be advantageous, especially for small and medium tears, and they called for additional high-quality research, including larger randomized controlled trials (RCTs).

More recently, in a systematic review and meta-analysis, Mazuquin et al. (2021) further explored the effectiveness of early versus delayed rehabilitation for patients who have received RCT repair. The study encompassed twenty randomized controlled trials involving a total of 1,841 patients. The authors noted significant variations in the rehabilitation protocols, including the timing of sling use and the progression of exercises. They highlighted that despite rotator cuff repair being a common surgical procedure, postoperative rehabilitation practices have largely remained unchanged for over two decades. The findings from their review indicated that patients who engaged in early rehabilitation may achieve a greater ROM sooner without increasing the risk of compromising the repair integrity-an ongoing concern for clinicians, especially shoulder orthopedic surgeons. The authors urged the need for a large, high-quality randomized controlled trial that encompasses all sizes of RCTs, emphasizing a more progressive and individualized approach to early rehabilitation. This approach should involve a gradual introduction of active arm use as soon as feasible, always within the limits of the individual patient's pain tolerance. This is the motivation of this current study. This study aims to evaluate the effectiveness of early versus delayed rehabilitation following rotator cuff repairs.

Objective and Hypotheses The primary objective of this randomized controlled trial (RCT) is to assess the effectiveness of early rehabilitation compared to delayed rehabilitation in patients who have undergone rotator cuff tear (RCT) repair. The hypothesis posits that early rehabilitation will result in superior outcomes concerning shoulder pain and function when compared to the conservative approach.

Research Question Is early rehabilitation more effective in enhancing shoulder outcomes post-RCT repair than delayed rehabilitation?

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital and Research Centre
        • Principal Investigator:
          • COLLINS OGBEIVOR, PhD
        • Contact:
        • Sub-Investigator:
          • Thamer Alraiyes, MD
        • Sub-Investigator:
          • Raed Hashem, MD
        • Sub-Investigator:
          • Gamal Mohammed, PhD
        • Sub-Investigator:
          • Rozeena Huma, PhD
        • Sub-Investigator:
          • Osama Mohammed, MSc
        • Sub-Investigator:
          • Alimoddin Mohammed, BSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults aged 18 years and older
  2. Patients diagnosed with a symptomatic tear of the rotator cuff and listed for surgical repair
  3. Rotator cuff tear confirmed by MRI
  4. Patients screened by the surgeon as suitable to participate
  5. Able to attend out-patient follow-up physiotherapy appointment
  6. Demonstrate the ability and willingness to consent and continue participation in the study
  7. Able to understand Arabic or English Language

Exclusion Criteria:

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

  1. Individuals younger than 18 years
  2. Those unable or unwilling to consent or continue with the study.
  3. Moderate to severe arthritis seen on x rays or MRI
  4. Fatty infiltration grade >= 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
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)
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 Names:
  • Education and Advice
Experimental: Intervention arm
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
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 Names:
  • Therapeutic exercises
  • Education and advice
Other: Therapeutic exercises, education and advice
Intervention will be provided with passive exercises and education from day one after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain and disability score
Time Frame: From enrollment to the end of study at 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Estimated)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#2251676

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not supported by the hospital IRB requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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