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Clinical Trial NCT07501949 for Rotator Cuff Tear Surgical Repair is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery 80 Randomized

Not yet recruiting
Clinical Trial NCT07501949 is an interventional study for Rotator Cuff Tear Surgical Repair and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 80 participants. Led by Electronic Waveform Lab, this study is expected to complete by March 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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 randomize...Show More
Official Title

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

Conditions
Rotator Cuff Tear Surgical Repair
Other Study IDs
  • EWL - 2026/PORCR
NCT ID Number
NCT07501949
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-03-31
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Rotator Cuff Tear
Electrical Stimulation
HWDS
H-Wave
H-Wave Device Stimulation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRoutine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Active ComparatorRoutine post-surgical care
Routine post-surgical care
Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 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 Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
Electronic Waveform Lab logoElectronic Waveform Lab
Study Central Contact
Contact: William J. Heaney Jr., 213-268-2619, [email protected]
Contact: Heather Gorman, 714-951-1917, [email protected]
4 Study Locations in 1 Countries

Kansas

Sano, Overland Park, Kansas, 66211, United States
Becky Jones, Contact, 512-468-8357, [email protected]
Michael J. Dempewolf, DO, MBA, Contact, 816-525-2840, [email protected]
Michael J. Dempewolf, DO, MBA, Principal 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, Sub-Investigator

Missouri

Sano, Kansas City, Missouri, 64151, United States
Becky Jones, Contact, 512-468-8357, [email protected]
Michael J. Dempewolf, DO, MBA, Contact, 816-525-2840, [email protected]
Michael J. Dempewolf, DO, MBA, Principal 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
Sano, Lee's Summit, Missouri, 64064, United States
Becky Jones, Contact, 512-468-8357, [email protected]
Michael J. Dempewolf, DO, MBA, Contact, 816-525-2840, [email protected]
Michael J. Dempewolf, DO, MBA, Principal 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
Sano, Raymore, Missouri, 64083, United States
Becky Jones, Contact, 512-468-8357, [email protected]
Michael J. Dempewolf, DO, MBA, Contact, 816-525-2840, [email protected]
Michael J. Dempewolf, DO, MBA, Principal 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