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

NCT07501949 | Not Yet Recruiting FDA Device

• 1 other identifier: EWL - 2026/PORCR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Rotator Cuff Tear Surgical Repair

Keywords

Rotator Cuff Tear; Electrical Stimulation; HWDS; H-Wave; H-Wave Device Stimulation

Outcome Measures

Primary Outcomes (7)

• 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 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). Change at follow-up visit(s) compared to baseline will be evaluated.

  Baseline, 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 Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)

  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 Outcomes (1)

• Change in Active/Passive Range of Motion (AROM/PROM)

  Baseline, 2 months and 3 months

Study Arms (2)

Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)

EXPERIMENTAL

Device: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)

Routine post-surgical care

ACTIVE COMPARATOR

Other: Routine post-surgical care

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 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

Routine post-surgical care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of full-thickness, or partial requiring surgical detachment, rotator cuff tear
• Primary rotator cuff repair (reattachment), with or without other necessary procedures, (e.g., biceps tenodesis, distal clavicle resection)
• Age 18-64 at time of enrollment
• Body mass index (BMI) \<40 Kg/m2
• 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
• 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
• Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent
• Be willing and capable of complying with study-related requirements, procedures, and follow-up visits

You may not qualify if:

• 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
• Morbid obesity with BMI ≥40 Kg/m2
• Pregnancy as determined by urine testing (unless surgically sterile or post-menopausal)
• Actively breastfeeding or desiring pregnancy during the study
• Prior H-Wave® device stimulation use
• Use of other home devices (e.g., TENS) within 2 weeks of screening visit
• Major psychological or psychiatric disorder
• Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation
• Addiction or substance abuse history to opioids, controlled substances, alcohol, or illicit drugs
• Injectable steroids within 8 weeks of screening visit
• History of progressive neurological disease
• History of immunosuppressive medication/treatment or cancer diagnosis within 5 years
• History of uncontrolled autoimmune disorders
• History of organ or hematologic transplantation
• Reported pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, or confound study evaluations

Sponsors & Collaborators

• Electronic Waveform Lab: lead

Study Sites (4)

Sano

Overland Park, Kansas, 66211, United States

Location

Sano

Kansas City, Missouri, 64151, United States

Location

Sano

Lee's Summit, Missouri, 64064, United States

Location

Sano

Raymore, Missouri, 64083, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Stephen M. Norwood, MD, FAAOS

  Orthopaedic Surgeon

  STUDY DIRECTOR

• Michael J. Dempewolf, DO, MBA

  Sano Orthopaedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William J. Heaney Jr.

CONTACT

213-268-2619; BDshows@h-wave.com

Heather Gorman

CONTACT

714-951-1917; hgorman@h-wave.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (4)