Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Posterior Shoulder Pillow
- Conventional Rehabilitation Protocol
Treatment groups
126 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov