Treating Chronic Pain of Peripheral Nerve Origin With the Novel Noninvasive Hypersound Neuromodulation System
Not yet recruitingEarly phase 1NCT06626854
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.
Study details
- Official title
- Prospective, Randomized Study to Assess the Safety and Efficacy of the Novel Noninvasive Hypersound Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin, Including Neuropathy, Sciatica, and Joint Pain
- Conditions
- Chronic Knee Pain
- Chronic Knee Osteoarthritis
- Post Surgical Neuropathic Pain
- Interventions
- Device: RF-PNS
- Sponsor
- Hypersound Medical Inc
- Start date
- 2026-06-10
- Primary completion
- 2026-10-10
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Pain greater than mid-range using standardized pain inventory (SPI). * No medication for pain both over-the-counter and by prescription for 24 hours prior to treatment. * Body mass index (BMI) to be calculated for all participants with limitation for any BMI that is lower than normal. (Target is normal, overweight or obese). * Age greater than 18. Exclusion Criteria: * Existing Peripheral Nerve Stimulator Implant in the lower extremities
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06626854