Hypersound Treatment for Chronic Neuropathic and Radicular Pain

ClinicalTrials.gov ID: NCT07831447

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Official title

A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07831447
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Hypersound Medical Inc; Industry
Enrollment: 71 participants

Conditions and interventions

Conditions

Interventions

Hypersound RF-PNS system Device
Sham Hypersound Device

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2027 (Estimated)
Primary completion: Mar 2028 (Estimated)
Completion: Jun 2028 (Estimated)
Last update posted: Sep 21, 2026

2027 – 2028

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Center for Pain and Supportive Care	Phoenix	Arizona	85028	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07831447, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 21, 2026 · Synced Nov 14, 2026