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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Pillow Group | Experimental | Patients who receive the standardized use of the posterior shoulder pillow in addition to the conventional rehabilitation protocol. |
|
| Conventional Rehabilitation Group | Active Comparator | Patients who receive the conventional rehabilitation protocol only, without standardized use of the pillow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Shoulder Pillow | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From pre-operation (baseline) to 6 weeks post-operation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From pre-operation (baseline) to 6 weeks post-operation. Measured at 2 weeks, 4 weeks, and 6 weeks post-operation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Assessed at the end of the study (after 6-week data collection). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenlong Liu | Contact | 13261993917 | zhenlong_liu@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D010149 | Pain, Postoperative |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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|
| Conventional Rehabilitation Protocol | Other | 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. |
|
| 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 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 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. | 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). |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |