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

Official title

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

Overview

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

• Device Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
  Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
• Other Routine post-surgical care
  Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications

Primary outcome measures

• Change in Pain Medication Usage [Time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in pain intensity assessed via Visual Analogue Scale (VAS) [Time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in pain intensity assessed via Brief Pain Inventory (BPI) [Time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES) [Time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score [Time frame: Baseline, 2 months and 3 months]
• Change in Single Assessment Numeric Evaluation (SANE) [Time frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months]
• 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]

Secondary outcome measures (1)

• Change in Active/Passive Range of Motion (AROM/PROM) [Time frame: Baseline, 2 months and 3 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Sano — Overland Park
• Sano — Kansas City
• Sano — Lee's Summit
• Sano — Raymore

Identifiers

NCT: NCT07501949 · EWL - 2026/PORCR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗