Rotator Cuff Tear Surgical RepairNCT07501949
H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery
A study testing Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) and Routine post-surgical care in people with Rotator Cuff Tear Surgical Repair, run by Electronic Waveform Lab at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rotator Cuff Tear Surgical Repair
- What is being tested?
- Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) and Routine post-surgical care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Implanted pacemaker, SCS, or other devices deemed unfit for inclusion by principal investigator
- 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
- Participated in another clinical study or received treatment with any investigational product within 30 days
- 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
- Has any other condition(s) that, in the investigator's opinion, might indicate that the subject is unsuitable for the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Sano
Kansas City, Missouri, 64151
Becky Jones, 512-468-8357, beckyofkansascity@gmail.com
Michael J. Dempewolf, DO, MBA, 816-525-2840, mdempewolf@sanokc.com
Sano
Lee's Summit, Missouri, 64064
Becky Jones, 512-468-8357, beckyofkansascity@gmail.com
Michael J. Dempewolf, DO, MBA, 816-525-2840, mdempewolf@sanokc.com
Sano
Overland Park, Kansas, 66211
Becky Jones, 512-468-8357, beckyofkansascity@gmail.com
Michael J. Dempewolf, DO, MBA, 816-525-2840, mdempewolf@sanokc.com
Sano
Raymore, Missouri, 64083
Becky Jones, 512-468-8357, beckyofkansascity@gmail.com
Michael J. Dempewolf, DO, MBA, 816-525-2840, mdempewolf@sanokc.com
About this study
Official title: 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.
- Conditions
- Rotator Cuff Tear Surgical Repair
- Being tested
- Routine post-surgical care plus H-Wave® Device Stimulation (HWDS), Routine post-surgical care
- Keywords
- Rotator Cuff Tear, Electrical Stimulation, HWDS, H-Wave, H-Wave Device Stimulation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)Device
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical careOther
Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications
| Study group | Role | What they receive |
|---|---|---|
| Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) | Experimental | Not described Receives: Device: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) |
| Routine post-surgical care | Active comparator | Not described Receives: Other: Routine post-surgical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6-8days, 3-4weeks, 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.
Measured: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Secondary outcomes (1)
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.
Measured: Baseline, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear Surgical RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Electronic Waveform Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen M. Norwood, MD, FAAOS, Study director, Orthopaedic SurgeonMichael J. Dempewolf, DO, MBA, Principal investigator, Sano Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501949
- Sponsor's protocol ID
- EWL - 2026/PORCR
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery: A Prospective, Single-center, Double-Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07501949
- Acronym / sponsor ID
- EWL - 2026/PORCR
- Conditions
- Rotator Cuff Tear Surgical Repair
- Keywords
- Rotator Cuff Tear, Electrical Stimulation, HWDS, H-Wave, H-Wave Device Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Electronic Waveform LabIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) | Device | Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) |
| Routine post-surgical careRoutine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications | Other | Routine post-surgical care |
Primary outcome
Change in Pain Medication Usage
Time frame: Baseline, 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Score
Time frame: Baseline, 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Change in Active/Passive Range of Motion (AROM/PROM)
Time frame: Baseline, 2 months and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen M. Norwood, MD, FAAOS study director
Orthopaedic Surgeon
Michael J. Dempewolf, DO, MBA principal investigator
Sano Orthopaedics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine post-surgical care plus H-Wave® Device Stimulation (HWDS) and Routine post-surgical care in people with Rotator Cuff Tear Surgical Repair, run by Electronic Waveform Lab at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William J. Heaney Jr. (213-268-2619, BDshows@h-wave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Medication Usage (time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.