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

Conditions

• Rotator Cuff Tear Surgical Repair

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) — DEVICE
  Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
• Routine post-surgical care — OTHER
  Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications

Study Details

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 Dates

Start date

Apr 1, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
• Active Comparator: Routine post-surgical care

Primary Outcome Measure

Change in Pain Medication Usage [ Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months ]

Central Contacts

• William J. Heaney Jr.
  213-268-2619
  [email protected]
• Heather Gorman
  714-951-1917
  [email protected]

Locations (4)

Find similar trials in Overland Park, KS