Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior Shoulder Pillow, Conventional Rehabilitation Protocol.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Injuries, Postoperative Pain, Sleep Quality. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair: A Prospective Cohort Study
Overview
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.
Interventions
- Device Posterior Shoulder Pillow
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. - Other Conventional Rehabilitation Protocol
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 outcome measures
- Pain Score Measured by Visual Analog Scale (VAS) [Time frame: From pre-operation (baseline) to 6 weeks post-operation.]
- Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: From pre-operation (baseline) to 6 weeks post-operation.]
Secondary outcome measures (4)
- Shoulder Function [Time frame: 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 [Time frame: Measured at pre-operation (baseline) and at 6 weeks post-operation.]
- Muscle Fatty Infiltration Assessed by the Goutallier Classification on MRI [Time frame: Measured at pre-operation (baseline) and at 6 weeks post-operation.]
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07372222 · M20250422