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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHypersound Medical Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Existing Peripheral Nerve Stimulator Implant in the lower extremities

Trial design

Design model

Single group

Treatments tested in this trial

  • RF-PNS

    Device

    Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VAS

Visual Analog Score Improvement of 50%

Time frame
3 months

Secondary outcomes

1

Disability

Oswestry disability index improvement of greater than 50%

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: