Rotator Cuff Tear Surgical Repair
Conditions
Keywords
Rotator Cuff Tear, Electrical Stimulation, HWDS, H-Wave, H-Wave Device Stimulation
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.
Interventions
DEVICERoutine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
OTHERRoutine post-surgical care
Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications
Sponsors
Electronic Waveform Lab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Medication Usage | 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) | 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 Score | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Active/Passive Range of Motion (AROM/PROM) | Baseline, 2 months and 3 months | 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. |
Countries
United States
Contacts
CONTACTWilliam J. Heaney Jr.
CONTACTHeather Gorman
STUDY_DIRECTORStephen M. Norwood, MD, FAAOS
Orthopaedic Surgeon
PRINCIPAL_INVESTIGATORMichael J. Dempewolf, DO, MBA
Sano Orthopaedics
Outcome results
None listed