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NCT Number: NCT07372222

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

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.

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Key information

Conditions

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

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Score Measured by Visual Analog Scale (VAS)

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

    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.

  2. Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI)

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

    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.

Secondary outcomes

  1. Shoulder Function

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

    Assessed by the Constant-Murley Score (CMS). The score ranges from 0 to 100, assessing pain, activities of daily living, range of motion, and strength, with higher scores indicating better function.

  2. Tendon Healing Status Assessed by the Sugaya Classification on MRI

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

    Tendon integrity and healing will be evaluated on MRI using the Sugaya classification system. This is a 5-point scale (Type I-V) based on signal intensity and thickness of the repaired tendon, where Type I represents a fully healed tendon with sufficient thickness and low signal intensity, and Type V represents a re-tear. Lower grades indicate better tendon healing.

  3. Muscle Fatty Infiltration Assessed by the Goutallier Classification on MRI

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

    The degree of fatty infiltration of the supraspinatus muscle will be evaluated on MRI using the Goutallier classification system. This is a 5-stage scale (Grade 0-4), where Grade 0 represents no fatty infiltration and Grade 4 represents >80% fatty infiltration. Higher grades indicate worse fatty degeneration.

  4. Incidence of Complications

    Time frame: 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).

    The occurrence of any adverse events related to the pillow use or rehabilitation, such as skin pressure ulcers, discomfort caused by the pillow, infection, etc.

Other outcomes

  1. Subgroup Analysis of Intervention Effects

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

    To explore the consistency of the intervention effect across different subgroups, as pre-specified in the study protocol. Subgroups are defined by:

    • Surgical technique (single-row vs. double-row suture repair)
    • Tear size/grade of rotator cuff tear

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenlong Liu

CONTACT

[email protected]

13261993917

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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