Rotator Cuff InjuriesNCT07372222
Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair
A study testing Posterior Shoulder Pillow and Conventional Rehabilitation Protocol in people with Rotator Cuff Injuries and Postoperative Pain, run by Peking University Third Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries, Postoperative Pain, Sleep Quality
- What is being tested?
- Posterior Shoulder Pillow and Conventional Rehabilitation Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair: A Prospective Cohort Study
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.
Read more
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.
- Conditions
- Rotator Cuff Injuries, Postoperative Pain, Sleep Quality
- Being tested
- Posterior Shoulder Pillow, Conventional Rehabilitation Protocol
- Keywords
- Pillows, Rotator Cuff Repair, Postoperative Pain, Sleep Quality, Randomized Controlled Trial
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Shoulder PillowDevice
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Pillow Group | Experimental | Patients who receive the standardized use of the posterior shoulder pillow in addition to the conventional rehabilitation protocol. Receives: Device: Posterior Shoulder Pillow; Other: Conventional Rehabilitation Protocol |
| Conventional Rehabilitation Group | Active comparator | Patients who receive the conventional rehabilitation protocol only, without standardized use of the pillow. Receives: Other: Conventional Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-operation (baseline) to 6 weeks post-operation.
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.
Measured: From pre-operation (baseline) to 6 weeks post-operation.
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: Measured at pre-operation (baseline) and at 6 weeks post-operation.
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.
Measured: Measured at pre-operation (baseline) and at 6 weeks post-operation.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startSep 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhenlong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372222
- Sponsor's protocol ID
- M20250422
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07372222
- Acronym / sponsor ID
- M20250422
- Conditions
- Rotator Cuff Injuries, Postoperative Pain, Sleep Quality
- Keywords
- Pillows, Rotator Cuff Repair, Postoperative Pain, Sleep Quality, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Pillow Group | Experimental | Device: Posterior Shoulder Pillow, Other: Conventional Rehabilitation ProtocolPatients who receive the standardized use of the posterior shoulder pillow in addition to the conventional rehabilitation protocol. |
| Conventional Rehabilitation Group | Active comparator | Other: Conventional Rehabilitation ProtocolPatients who receive the conventional rehabilitation protocol only, without standardized use of the pillow. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Shoulder PillowThis 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. | Device | Posterior Pillow Group |
| Conventional Rehabilitation ProtocolThis 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. | Other | Conventional Rehabilitation Group, Posterior Pillow Group |
Primary outcome
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.
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.
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Shoulder Pillow and Conventional Rehabilitation Protocol in people with Rotator Cuff Injuries and Postoperative Pain, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenlong Liu (13261993917, zhenlong_liu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Measured by Visual Analog Scale (VAS) (time frame: From pre-operation (baseline) to 6 weeks post-operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.