Hypersound Treatment for Chronic Neuropathic and Radicular Pain
Not yet recruitingNot applicableNCT07831447
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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)
This study will evaluate whether the investigational Hypersound system reduces pain in adults with chronic neuropathic or radicular pain. Hypersound uses externally positioned antennas to deliver radiofrequency energy intended to stimulate peripheral nerves without an implant. Approximately 71 participants will be randomly assigned in a two-to-one ratio to active Hypersound or sham treatment. Treatment consists of ten 15-minute sessions, twice weekly over five weeks. Participants will be unaware of their assigned treatment. The main comparison is the percentage of participants with at least a 50% decrease in average pain intensity at 90 days after the first treatment. Pain will be measured using a 100-mm visual analog scale referring to average pain over the preceding 24 hours. Safety and additional measures of pain and daily functioning will also be assessed. Participants initially assigned to sham will be offered active treatment after the 90-day assessment and followed for another 90 days after their first active treatment.
Study details
- Official title
- A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain
- Conditions
- Chronic Neuropathic Pain
- Radiculopathy
- Sciatica
- Peripheral Neuropathic Pain
- Interventions
- Device: Hypersound RF-PNS system
- Device: Sham Hypersound
- Sponsor
- Hypersound Medical Inc
- Start date
- 2027-06
- Primary completion
- 2028-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 18 years or older. * Clinically confirmed chronic neuropathic or radicular pain of at least three months' duration. * An identifiable anatomical treatment target. * Baseline pain meeting the minimum intensity threshold specified in the protocol. * Stable pain-treatment regimen as defined in the protocol. * Able to provide informed consent and to complete patient-reported assessments. * Willing to complete the treatment course and follow-up visits. Exclusion Criteria: * Unstable medical or neurological disease. * Another dominant source of pain that would interfere with evaluation of the target pain condition. * Inability to reliably report outcomes. * Contraindications to the investigational device as specified in the protocol. * Major recent changes in pain treatment, as defined in the protocol. * Participation in another intervention likely to materially affect study outcomes.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07831447