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

Starting soon · Not applicable

Conditions studied: Rotator Cuff Tear Surgical Repair

In brief

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.

Key facts

Study ID: NCT07501949
Run by: Electronic Waveform Lab
People needed: 80
Starts: 2026-04-01
Expected to finish: 2027-03-31
Last updated by the study team: 2026-04-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Sano — Overland Park, Kansas, United States
Sano — Kansas City, Missouri, United States
Sano — Lee's Summit, Missouri, United States
Sano — Raymore, Missouri, United States

Full record on ClinicalTrials.gov

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