Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair

NCT07372222 | Not Yet Recruiting DMC

• 1 other identifier: M20250422
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical study is to learn if using a special pillow placed behind the shoulder can help to reduce pain and improve sleep for patients after surgery to repair a torn rotator cuff. The main questions it aims to answer are:

• Do patients who choose to use the posterior shoulder pillow have lower pain levels after surgery?
• Do these patients report better sleep quality during recovery?
• How safe and comfortable is the pillow for patients to use? Researchers will compare patients who use the pillow to those who do not use it to see if there is a difference in their recovery. Participants will:
• Be asked about their willingness to use the pillow. Their treatment and recovery plan will be decided together with their doctor.
• Be asked to rate their pain and sleep quality several times after surgery: at 1 week, 2 weeks, 4 weeks, and 6 weeks.
• Have their shoulder function assessed by a clinician at 2, 4, and 6 weeks after surgery.
• Receive a standard MRI scan before and 6 weeks after surgery as part of their regular medical care to check on healing.

Conditions

Postoperative Pain; Sleep Quality; Rotator Cuff Injuries

Keywords

Pillows; Rotator Cuff Repair; Postoperative Pain; Sleep Quality; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Pain Score Measured by Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) for pain is a 100-mm horizontal line where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Higher scores indicate worse pain.

  From pre-operation (baseline) to 6 weeks post-operation.

• Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month interval. The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.

  From pre-operation (baseline) to 6 weeks post-operation.

Secondary Outcomes (4)

• Shoulder Function

  From pre-operation (baseline) to 6 weeks post-operation. Measured at 2 weeks, 4 weeks, and 6 weeks post-operation.

• Tendon Healing Status Assessed by the Sugaya Classification on MRI

  Measured at pre-operation (baseline) and at 6 weeks post-operation.

• Muscle Fatty Infiltration Assessed by the Goutallier Classification on MRI

  Measured at pre-operation (baseline) and at 6 weeks post-operation.

• Incidence of Complications

  From immediately after intervention initiation up to 6 weeks post-operation. Assessed at each follow-up visit (24 hours, 1 week, 2 weeks, 4 weeks, 6 weeks).

Other Outcomes (1)

• Subgroup Analysis of Intervention Effects

  Assessed at the end of the study (after 6-week data collection).

Study Arms (2)

Posterior Pillow Group

EXPERIMENTAL

Patients who receive the standardized use of the posterior shoulder pillow in addition to the conventional rehabilitation protocol.

Device: Posterior Shoulder Pillow; Other: Conventional Rehabilitation Protocol

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Patients who receive the conventional rehabilitation protocol only, without standardized use of the pillow.

Other: Conventional Rehabilitation Protocol

Interventions

Posterior Shoulder Pillow DEVICE

This is a standardized protocol for using a regular hospital ward pillow placed behind the shoulder (between the scapula and the bed) after arthroscopic rotator cuff repair. Patients in the intervention group are instructed to start using the pillow within 24 hours after surgery and maintain its use during rest and sleep for the 6-week study period. The pillow aims to provide support and improve comfort.

Posterior Pillow Group

Conventional Rehabilitation Protocol OTHER

This is the standard post-operative care for patients undergoing arthroscopic rotator cuff repair. It includes cryotherapy (ice packs), pharmacological analgesia (pain medication), and a progressive program of functional exercises guided by a physical therapist. This protocol is administered to all patients in the study, regardless of group assignment.

Conventional Rehabilitation Group; Posterior Pillow Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a rotator cuff tear, confirmed by imaging (MRI or ultrasound), and deemed suitable for either single-row or double-row arthroscopic repair surgery.
• Age between 40 and 70 years.
• Willing and able to provide written informed consent to participate in the study.
• Demonstrates good compliance with postoperative rehabilitation and follow-up requirements.

You may not qualify if:

• Presence of concomitant shoulder pathologies, such as glenohumeral osteoarthritis, adhesive capsulitis, history of labral repair, or irreparable tendon tears.
• Pre-existing severe shoulder infection, tumor, or other conditions that may significantly impact postoperative recovery.
• Previous history of shoulder surgery or severe shoulder deformity that could confound the assessment of postoperative outcomes.
• Cognitive impairment or inability to understand the pain assessment tools (e.g., VAS score).
• Significant comorbidities affecting the heart, liver, or kidneys, or requiring long-term use of medications that affect coagulation (e.g., aspirin).
• Diagnosis of malignant tumors or rheumatic autoimmune diseases that may interfere with postoperative recovery.
• MRI findings indicating significant fatty infiltration (\>50%) or tendon retraction, suggesting potential compromise in surgical outcome and recovery.
• Superior migration of the humeral head or obliteration of the coracoacromial space, indicating a high difficulty of rotator cuff repair.
• Contraindications to postoperative rehabilitation exercises, such as severe osteoporosis or neuromuscular diseases.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Zhenlong Liu

CONTACT

13261993917; zhenlong_liu@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share