An interventional study of Posterior Shoulder Pillow and Conventional Rehabilitation Protocol in Rotator Cuff Injuries, Postoperative Pain and Sleep Quality, sponsored by Peking University Third Hospital. Not yet recruiting. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
Among 14 studies in Rotator Cuff Injuries by Peking University Third Hospital — 6 open to participants now, 6 under way, none of them phase 3. Rotator Cuff Injuries · Peking University Third Hospital.
Among the 14 studies in Rotator Cuff Injuries by Peking University Third Hospital, this one is one of 2 that started in 2026, is one of 6 with no phase, and was the 13th registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 126 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →6 of the 14 studies in Rotator Cuff Injuries by Peking University Third Hospital are open now, in 1 country. Each count lists the studies.
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 40 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2026.
Median enrollment 61 across the 6 interventional studies, 167 across the 8 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Rotator Cuff Injuries by Peking University Third Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who receive the standardized use of the posterior shoulder pillow in addition to the conventional rehabilitation protocol.
Device: Posterior Shoulder Pillow · Other: Conventional Rehabilitation Protocol
Patients who receive the conventional rehabilitation protocol only, without standardized use of the pillow.
Other: Conventional Rehabilitation Protocol
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.
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.
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.
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.
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.
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.
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.
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).
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).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 228 non-industry interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 15 months is below that.
Counting every sponsor, half of 252 studies reached it within 23 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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