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

Efficacy of H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery: A Prospective, Single-center, Double-Blinded, Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear Surgical Repair
• Intervention / Treatment: Device: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS); Other: Routine post-surgical care

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William J. Heaney Jr.; Phone Number: 213-268-2619; Email: BDshows@h-wave.com
• Study Contact Backup: Name: Heather Gorman; Phone Number: 714-951-1917; Email: hgorman@h-wave.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Sano
      • Contact: Becky Jones; Phone Number: 512-468-8357; Email: beckyofkansascity@gmail.com
      • Contact: Michael J. Dempewolf, DO, MBA; Phone Number: 816-525-2840; Email: mdempewolf@sanokc.com
      • Principal Investigator: Michael J. Dempewolf, DO, MBA
      • Sub-Investigator: Matthew Dagget, DO, MBA
      • Sub-Investigator: Andrew Witte, DO, MBA
      • Sub-Investigator: Matthew Cullen, DO
      • Sub-Investigator: John Swab, DO
      • Sub-Investigator: Christopher Eckland, DO
      • Sub-Investigator: Daniel Farrell, MS, MD, FAAOS
  • Missouri
    • Kansas City, Missouri, United States, 64151
      • Sano
      • Contact: Becky Jones; Phone Number: 512-468-8357; Email: beckyofkansascity@gmail.com
      • Contact: Michael J. Dempewolf, DO, MBA; Phone Number: 816-525-2840; Email: mdempewolf@sanokc.com
      • Principal Investigator: Michael J. Dempewolf, DO, MBA
      • Sub-Investigator: Matthew Dagget, DO, MBA
      • Sub-Investigator: Andrew Witte, DO, MBA
      • Sub-Investigator: Matthew Cullen, DO
      • Sub-Investigator: John Swab, DO
      • Sub-Investigator: Christopher Eckland, DO
    • Lee's Summit, Missouri, United States, 64064
      • Sano
      • Contact: Becky Jones; Phone Number: 512-468-8357; Email: beckyofkansascity@gmail.com
      • Contact: Michael J. Dempewolf, DO, MBA; Phone Number: 816-525-2840; Email: mdempewolf@sanokc.com
      • Principal Investigator: Michael J. Dempewolf, DO, MBA
      • Sub-Investigator: Matthew Dagget, DO, MBA
      • Sub-Investigator: Andrew Witte, DO, MBA
      • Sub-Investigator: Matthew Cullen, DO
      • Sub-Investigator: John Swab, DO
      • Sub-Investigator: Christopher Eckland, DO
    • Raymore, Missouri, United States, 64083
      • Sano
      • Contact: Becky Jones; Phone Number: 512-468-8357; Email: beckyofkansascity@gmail.com
      • Contact: Michael J. Dempewolf, DO, MBA; Phone Number: 816-525-2840; Email: mdempewolf@sanokc.com
      • Principal Investigator: Michael J. Dempewolf, DO, MBA
      • Sub-Investigator: Matthew Dagget, DO, MBA
      • Sub-Investigator: Andrew Witte, DO, MBA
      • Sub-Investigator: Matthew Cullen, DO
      • Sub-Investigator: John Swab, DO
      • Sub-Investigator: Christopher Eckland, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 providing written informed consent to participate in the clinical study based on voluntary agreement, following thorough explanation of subject participation
7. Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent
8. Be willing and capable of complying with study-related requirements, procedures, and follow-up visits

Exclusion Criteria:

1. Excluded diagnosis and/or procedure and/or symptoms including infection, tumor, partial-thickness rotator cuff tear (not requiring surgical detachment), or other primary non-rotator cuff tear related shoulder surgery
2. Morbid obesity with BMI ≥40 Kg/m2
3. Pregnancy as determined by urine testing (unless surgically sterile or post-menopausal)
4. Actively breastfeeding or desiring pregnancy during the study
5. Prior H-Wave® device stimulation use
6. Use of other home devices (e.g., TENS) within 2 weeks of screening visit
7. Major psychological or psychiatric disorder
8. Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation
9. Addiction or substance abuse history to opioids, controlled substances, alcohol, or illicit drugs
10. Injectable steroids within 8 weeks of screening visit
11. Implanted pacemaker, SCS, or other devices deemed unfit for inclusion by principal investigator
12. History of progressive neurological disease
13. History of immunosuppressive medication/treatment or cancer diagnosis within 5 years
14. History of uncontrolled autoimmune disorders
15. History of organ or hematologic transplantation
16. Reported pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, or confound study evaluations
17. Participated in another clinical study or received treatment with any investigational product within 30 days
18. From a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to employees (temporary, part- time, full-time) or family members of the research staff conducting the study, or of the sponsor, contract research organization, or IRB/IEC
19. Has any other condition(s) that, in the investigator's opinion, might indicate that the subject is unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 plus H-Wave® Device Stimulation (HWDS)
Active Comparator: Routine post-surgical care	Other: Routine post-surgical care; Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Medication Usage	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in pain intensity assessed via Visual Analogue Scale (VAS)	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in pain intensity assessed via Brief Pain Inventory (BPI)	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES)	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in Single Assessment Numeric Evaluation (SANE)	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score	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.	Baseline, 2 months and 3 months
Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)	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.	Baseline, 6-8days, 3-4weeks, 2 months and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Active/Passive Range of Motion (AROM/PROM)	Clinician will record Active and Passive Range of Motion for both Unaffected and Affected Shoulders. Change at follow-up visit(s) compared to baseline will be evaluated.	Baseline, 2 months and 3 months

Collaborators and Investigators

• Sponsor: Electronic Waveform Lab
• Investigators: Study Director: Stephen M. Norwood, MD, FAAOS, Orthopaedic Surgeon; Principal Investigator: Michael J. Dempewolf, DO, MBA, Sano Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Electrical Stimulation; Rotator Cuff Tear; H-Wave; HWDS; H-Wave Device Stimulation
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: EWL - 2026/PORCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No