H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery

Официальное название

Efficacy of H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery: A Prospective, Single-center, Double-Blinded, Randomized Controlled Trial

Обзор

The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery. It is hypothesized that HWDS initiated immediately upon home arrival following rotator cuff repair will not only result in earlier range of motion recovery, but also in better pain relief, medication reduction, sleep quality, and functional recovery. The participants will be randomized into two groups: (a) Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications, (b) Routine post-surgical care plus H-Wave® Device Stimulation (HWDS); and will be followed for 3 months post-surgery.

Вмешательства

• Устройство Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
  Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
• Другое Routine post-surgical care
  Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications

Первичные конечные точки

• Change in Pain Medication Usage [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in pain intensity assessed via Visual Analogue Scale (VAS) [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in pain intensity assessed via Brief Pain Inventory (BPI) [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES) [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score [Срок оценки: Baseline, 2 months and 3 months]
• Change in Single Assessment Numeric Evaluation (SANE) [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI) [Срок оценки: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]

Вторичные конечные точки (1)

• Change in Active/Passive Range of Motion (AROM/PROM) [Срок оценки: Baseline, 2 months and 3 months]

Критерии участия

Критерии включения

• Diagnosis of full-thickness, or partial requiring surgical detachment, rotator cuff tear
• Primary rotator cuff repair (reattachment), with or without other necessary procedures, (e.g., biceps tenodesis, distal clavicle resection)
• Age 18-64 at time of enrollment
• Body mass index (BMI) <40 Kg/m2
• Females, sexually active and of childbearing age, must be willing to use a reliable form of birth control throughout study duration; Males, sexually active with partners of childbearing age must be willing to use contraceptive measures
• Be willing and capable of providing written informed consent to participate in the clinical study based on voluntary agreement, following thorough explanation of subject participation
• Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent
• Be willing and capable of complying with study-related requirements, procedures, and follow-up visits

Критерии исключения

• Excluded diagnosis and/or procedure and/or symptoms including infection, tumor, partial-thickness rotator cuff tear (not requiring surgical detachment), or other primary non-rotator cuff tear related shoulder surgery
• Morbid obesity with BMI ≥40 Kg/m2
• Pregnancy as determined by urine testing (unless surgically sterile or post-menopausal)
• Actively breastfeeding or desiring pregnancy during the study
• Prior H-Wave® device stimulation use
• Use of other home devices (e.g., TENS) within 2 weeks of screening visit
• Major psychological or psychiatric disorder
• Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation
• Addiction or substance abuse history to opioids, controlled substances, alcohol, or illicit drugs
• Injectable steroids within 8 weeks of screening visit
• Implanted pacemaker, SCS, or other devices deemed unfit for inclusion by principal investigator
• History of progressive neurological disease
• History of immunosuppressive medication/treatment or cancer diagnosis within 5 years
• History of uncontrolled autoimmune disorders
• History of organ or hematologic transplantation
• Reported pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, or confound study evaluations
• Participated in another clinical study or received treatment with any investigational product within 30 days
• From a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to employees (temporary, part- time, full-time) or family members of the research staff conducting the study, or of the sponsor, contract research organization, or IRB/IEC
• Has any other condition(s) that, in the investigator's opinion, might indicate that the subject is unsuitable for the study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Sano — Overland Park
• Sano — Kansas City
• Sano — Lee's Summit
• Sano — Raymore

Идентификаторы

NCT: NCT07501949 · EWL - 2026/PORCR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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