H-Wave® Device Stimulation for Rotator Cuff Repair

Not yet recruiting at 3 trial locations

Overseen By Heather Gorman

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Electronic Waveform Lab

Must not be taking: Injectable steroids

Disqualifiers: Morbid obesity, Pregnancy, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Stephen M. Norwood, MD, FAAOS

Principal Investigator

Orthopaedic Surgeon

Michael J. Dempewolf, DO, MBA

Principal Investigator

Sano Orthopaedics

Are You a Good Fit for This Trial?

Inclusion Criteria

Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent

I have a rotator cuff tear that needs surgery.

I am between 18 and 64 years old.

Exclusion Criteria

Prior H-Wave® device stimulation use

Use of other home devices (e.g., TENS) within 2 weeks of screening visit

Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive routine post-surgical care with or without H-Wave® Device Stimulation following rotator cuff repair surgery

3 months

Baseline, 6-8 days, 3-4 weeks, 2 months, and 3 months

Follow-up

Participants are monitored for changes in pain medication usage, pain intensity, functional outcomes, and sleep quality

3 months

Follow-up visits at 6-8 days, 3-4 weeks, 2 months, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• H-Wave® Device Stimulation

How Is the Trial Designed?

Group I: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) Experimental Treatment 1 Intervention

Group II: Routine post-surgical care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Electronic Waveform Lab

Lead Sponsor