H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery (NCT07501949) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery
United States80 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Medication Usage
Timeframe: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
2
Change in pain intensity assessed via Visual Analogue Scale (VAS)
Timeframe: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
3
Change in pain intensity assessed via Brief Pain Inventory (BPI)
Timeframe: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
4
Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES)
Timeframe: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
5
Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score
Timeframe: Baseline, 2 months and 3 months
6
Change in Single Assessment Numeric Evaluation (SANE)
Timeframe: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
7
Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)