Efficacy of H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery: A Prospective, Single-center, Double-Blinded, Randomized Controlled Trial
Electronic Waveform Lab
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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 provi…
Interventions
- DeviceRoutine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
- OtherRoutine post-surgical care
Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications
Locations (4)
- SanoOverland Park, Kansas
- SanoKansas City, Missouri
- SanoLee's Summit, Missouri
- SanoRaymore, Missouri