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H-Wave® Device Stimulation for Rotator Cuff Repair Recovery

This study is testing if adding H-Wave® Device Stimulation (HWDS) to standard care helps people recover after rotator cuff repair surgery. Researchers want to see if HWDS can lead to less pain, less need for pain medication, better sleep, and improved arm function. You could join if you are between 18 and 64 years old, have a full or partial rotator cuff tear needing surgery, and meet other health criteria. The study will compare two groups: one receiving routine post-surgical care, and another receiving routine care plus HWDS. The main goals are to see how pain medication use and pain levels change over three months after surgery.

Study design
This is an interventional study planning to enroll 80 participants. Participants will be randomly assigned to one of two groups: routine care or routine care plus H-Wave® Device Stimulation.
What's involved
Participants will be followed for three months after surgery. Pain and medication use will be assessed at baseline, 6-8 days, 3-4 weeks, 2 months, and 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months post-surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07501949

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

Not Yet Recruiting
NAAges 18–64InterventionalTreatment
Electronic Waveform Lab
~80 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)Routine post-surgical care

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Medication Usage
Measured over Baseline, 6-8days, 3-4weeks, 2 months and 3 months
+6 more outcomes measured

Conditions

Rotator Cuff Tear Surgical Repair

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Rupture of rotator cuff of shoulder

NCT07501949

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sano

    Overland Park, Kansasstudy coordinator listed

  • Sano

    Kansas City, Missouristudy coordinator listed

  • Sano

    Lee's Summit, Missouristudy coordinator listed

  • Sano

    Raymore, Missouristudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephen M. Norwood, MD, FAAOS · STUDY_DIRECTOR · Orthopaedic Surgeon
  • Michael J. Dempewolf, DO, MBA · PRINCIPAL_INVESTIGATOR · Sano Orthopaedics

Who to contact

William J. Heaney Jr.
[email protected]
213-268-2619
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Change in Pain Medication UsageBaseline, 6-8days, 3-4weeks, 2 months and 3 months

    Amount of opioids (converted into morphine milligram equivalents) and other polypharmacy will be recorded, and change in usage of pain medications at follow-up visit(s) compared to baseline will be determined.

  • Change in pain intensity assessed via Visual Analogue Scale (VAS)Baseline, 6-8days, 3-4weeks, 2 months and 3 months

    0-10 Visual Analog Scale (0 = no pain, 10 = worst imaginable) will be used. Change in Pain intensity at follow-up visit(s) compared to baseline will be evaluated.

  • Change in pain intensity assessed via Brief Pain Inventory (BPI)Baseline, 6-8days, 3-4weeks, 2 months and 3 months

    BPI Pain Items will be used (0- no pain, 10- pain as bad as you can imagine). Change in Pain intensity at follow-up visit(s) compared to baseline will be evaluated.

  • Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES)Baseline, 6-8days, 3-4weeks, 2 months and 3 months

    Patient-reported improvement in functional improvement assessed via ASES. It involves pain and activities of daily living (0- unable to do, 3- not difficult) questionnaire. Change in function at follow-up visit(s) compared to baseline will be evaluated.

  • Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder ScoreBaseline, 2 months and 3 months

    UCLA shoulder score records patient-reported date (pain, function and satisfaction) along with clinician-reported findings (range of motion). Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function. Change at follow-up visit(s) compared to baseline will be evaluated.

  • Change in Single Assessment Numeric Evaluation (SANE)Baseline, 6-8days, 3-4weeks, 2 months and 3 months

    Patient will report their affected joint and opposite side as a percentage of normal (0 to 100% scale with 100% being normal). Change at follow-up visit(s) compared to baseline will be evaluated.

  • Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)Baseline, 6-8days, 3-4weeks, 2 months and 3 months

    Rated on a scale of 0-21 (Score of 0-5: Good sleeper; \>5: Poor sleeper). Change in sleep quality at follow-up visit(s) compared to baseline will be evaluated.