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

Electronic Waveform Lab

Status: Not yet enrolling

Conditions: Rotator Cuff Tear Surgical Repair

Treatments: Other: Routine post-surgical care; Device: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07501949

EWL - 2026/PORCR

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of full-thickness, or partial requiring surgical detachment, rotator cuff tear
2. Primary rotator cuff repair (reattachment), with or without other necessary procedures, (e.g., biceps tenodesis, distal clavicle resection)
3. Age 18-64 at time of enrollment
4. Body mass index (BMI) <40 Kg/m2
5. 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
6. 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
7. Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent
8. Be willing and capable of complying with study-related requirements, procedures, and follow-up visits

Exclusion criteria

1. 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
2. Morbid obesity with BMI ≥40 Kg/m2
3. Pregnancy as determined by urine testing (unless surgically sterile or post-menopausal)
4. Actively breastfeeding or desiring pregnancy during the study
5. Prior H-Wave® device stimulation use
6. Use of other home devices (e.g., TENS) within 2 weeks of screening visit
7. Major psychological or psychiatric disorder
8. Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation
9. Addiction or substance abuse history to opioids, controlled substances, alcohol, or illicit drugs
10. Injectable steroids within 8 weeks of screening visit
11. Implanted pacemaker, SCS, or other devices deemed unfit for inclusion by principal investigator
12. History of progressive neurological disease
13. History of immunosuppressive medication/treatment or cancer diagnosis within 5 years
14. History of uncontrolled autoimmune disorders
15. History of organ or hematologic transplantation
16. Reported pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, or confound study evaluations
17. Participated in another clinical study or received treatment with any investigational product within 30 days
18. 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
19. Has any other condition(s) that, in the investigator's opinion, might indicate that the subject is unsuitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

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

Experimental group

Treatment:

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

Routine post-surgical care

Active Comparator group

Treatment:

Other: Routine post-surgical care