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

Electronic Waveform Lab4 个研究点分布在 1 个国家目标入组 80 人开始时间: 2026年4月1日最近更新: 2026年4月3日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 80
试验地点: 4
主要终点: Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)

Experimental

干预措施: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) (Device)

Routine post-surgical care

Active Comparator

干预措施: Routine post-surgical care (Other)

结局指标

主要结局

Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score

时间窗: Baseline, 2 months and 3 months

UCLA shoulder score records patient-reported date (pain, function and satisfaction) along with clinician-reported findings (range of motion). Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function. Change at follow-up visit(s) compared to baseline will be evaluated.

Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)