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

Peking University

Status: Begins enrollment this month

Conditions: Postoperative Pain; Sleep Quality; Rotator Cuff Injuries

Treatments: Other: Conventional Rehabilitation Protocol; Device: Posterior Shoulder Pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT07372222

M20250422

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups

Posterior Pillow Group

Experimental group

Description:

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

Treatment:

Device: Posterior Shoulder Pillow

Other: Conventional Rehabilitation Protocol

Conventional Rehabilitation Group

Active Comparator group

Description:

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

Treatment:

Other: Conventional Rehabilitation Protocol