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NCT Number: NCT06626854

Treating Chronic Pain of Peripheral Nerve Origin With the Novel Noninvasive Hypersound Neuromodulation System

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.

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Key information

Conditions

Chronic Knee Pain Chronic Knee Osteoarthritis Post Surgical Neuropathic Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

Subject will perform screening and informed consent
Baseline measurements will be taken
Subject will sit in chair with back support throughout duration of the session
Knee for treatment will be verified and marked
Technician will wrap antenna applicator strap around the lower leg, at the knee
Device is turned on and set to test mode to verify therapy location. Subject will verify when they feel a sensation covering their existing chronic knee pain. The power threshold for sensation is recorded.
Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
At the end of 15 minutes, post-therapy measurements are recorded

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF-PNS

Device

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Other names: Noninvasive PNS, Hypersound

Primary outcomes

VAS

Time frame: 3 months

Visual Analog Score Improvement of 50%

Secondary outcomes

Disability

Time frame: 3 months

Oswestry disability index improvement of greater than 50%

Study contacts

Contact information is provided by the study sponsor or research team.

Gobi Paramanandnam, MD, MHSM

CONTACT

[email protected]

(480) 889-0180

Tim Dickman, MS

CONTACT

[email protected]

(480) 278-9200

Sponsors and collaborators

Lead sponsor

Hypersound Medical Inc

Industry

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Oct 4, 2024
Registry last updated: Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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