H-Wave® Device Stimulation for Rotator Cuff Repair

Not yet recruiting at 3 trial locations
WJ
HG
Overseen ByHeather Gorman
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Electronic Waveform Lab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device called H-Wave® can enhance recovery after rotator cuff surgery. The device may improve movement, reduce pain, decrease medication use, and enhance sleep and overall recovery. Participants will receive either standard post-surgery care or standard care plus the H-Wave® device. Individuals who have undergone surgery for rotator cuff tears may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to potentially enhance their recovery experience with innovative care.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will have access to pain medications as part of routine post-surgical care.

What prior data suggests that the H-Wave® Device Stimulation is safe for rotator cuff repair?

Research has shown that the H-Wave® Device Stimulation (HWDS) is generally safe. In previous studies, over 96% of patients reported satisfaction with the treatment. Importantly, participants experienced no harmful effects, indicating no unexpected problems. The device effectively reduces pain and improves function, especially with prolonged use. These findings suggest that HWDS is well-tolerated and poses no significant safety risks for prospective clinical trial participants.12345

Why are researchers excited about this trial?

Most treatments for rotator cuff repair focus on surgical intervention followed by physical therapy to aid recovery. However, the H-Wave® Device Stimulation (HWDS) offers a unique approach by using a specific type of electrical stimulation to enhance healing. Unlike traditional methods, HWDS aims to reduce pain and improve blood flow to the affected area, which can accelerate recovery times. Researchers are excited about HWDS because it might offer faster pain relief and healing, potentially leading to quicker return to daily activities for patients.

What evidence suggests that H-Wave® Device Stimulation is effective for rotator cuff repair?

Studies have shown that the H-Wave® Device can help manage pain and improve recovery after rotator cuff surgery. In this trial, one group of participants will receive routine post-surgical care plus H-Wave® Device Stimulation. Research indicates that patients using this device experienced 42.7% less loss of shoulder movement compared to those who did not use it. Additionally, over 96% of patients reported positive outcomes, with no negative side effects noted. The device also reduces pain and the need for medication, which can be very beneficial during recovery. Overall, these findings suggest that the H-Wave® Device could facilitate a faster and more comfortable recovery after shoulder surgery.12567

Who Is on the Research Team?

SM

Stephen M. Norwood, MD, FAAOS

Principal Investigator

Orthopaedic Surgeon

MJ

Michael J. Dempewolf, DO, MBA

Principal Investigator

Sano Orthopaedics

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who are having primary rotator cuff repair surgery and can follow study instructions. Participants must have a BMI under 40, not be pregnant or breastfeeding, and cannot have certain medical conditions like infections, tumors, severe obesity, uncontrolled autoimmune disorders, or implanted devices like pacemakers.

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.
See 5 more

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
See 16 more

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

Trial Overview

The study compares standard post-surgery care to standard care plus H-Wave® Device Stimulation (HWDS) after rotator cuff repair. Patients are randomly assigned to one of the two groups and followed for three months to see if HWDS helps with pain relief and recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)Experimental Treatment1 Intervention
Group II: Routine post-surgical careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Electronic Waveform Lab

Lead Sponsor

Citations

H-Wave® Device Stimulation for Post-operative Rotator ...

The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery.

H-Wave device stimulation benefits chronic shoulder pain in ...

Over 96% patient satisfaction and no adverse events were reported. Subgroup analyses found benefit with longer device use and shorter pain ...

H-Wave® Device Stimulation for Post-operative Rotator Cuff ...

The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery.

Double Blind Post Operative Study Utilizing H‑Wave

At 90 days post op those that used H‑Wave had 42.7% less loss of internal rotation compared to those without H‑Wave. Albeit the small sample ...

H-Wave Research Archives

We're excited to share our newest peer-reviewed publication: H-Wave device stimulation benefits chronic shoulder pain in an observational cohort ...

Repetitive H-Wave® device stimulation and program induces ...

HWDS compared to PLACEBO induces a significant increase in range of motion in positive management of rotator cuff reconstruction.

(PDF) H-Wave device stimulation benefits chronic shoulder ...

Over 96% patient satisfaction and no adverse events were reported. Subgroup analyses found benefit with longer device use and shorter pain chronicity, while ...