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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Posterior Shoulder Pillow
DeviceThis 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 interventionThis 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Posterior Pillow GroupExperimental treatment 2 interventions
Group B: Conventional Rehabilitation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From pre-operation (baseline) to 6 weeks post-operation.2
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.
Time frame
From pre-operation (baseline) to 6 weeks post-operation.Secondary outcomes
1
Shoulder Function
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.
Time frame
From pre-operation (baseline) to 6 weeks post-operation. Measured at 2 weeks, 4 weeks, and 6 weeks post-operation.2
Tendon Healing Status Assessed by the Sugaya Classification on MRI
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.
Time frame
Measured at pre-operation (baseline) and at 6 weeks post-operation.3
Muscle Fatty Infiltration Assessed by the Goutallier Classification on MRI
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.
Time frame
Measured at pre-operation (baseline) and at 6 weeks post-operation.4
Incidence of Complications
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.
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).Other outcomes
1
Subgroup Analysis of Intervention Effects
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
Time frame
Assessed at the end of the study (after 6-week data collection).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: