Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair

Официальное название

Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair: A Prospective Cohort Study

Обзор

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.

Вмешательства

• Устройство Posterior Shoulder Pillow
  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.
• Другое Conventional Rehabilitation Protocol
  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.

Первичные конечные точки

• Pain Score Measured by Visual Analog Scale (VAS) [Срок оценки: From pre-operation (baseline) to 6 weeks post-operation.]
• Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: From pre-operation (baseline) to 6 weeks post-operation.]

Вторичные конечные точки (4)

• Shoulder Function [Срок оценки: 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 [Срок оценки: Measured at pre-operation (baseline) and at 6 weeks post-operation.]
• Muscle Fatty Infiltration Assessed by the Goutallier Classification on MRI [Срок оценки: Measured at pre-operation (baseline) and at 6 weeks post-operation.]
• Incidence of Complications [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07372222 · M20250422

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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