Treating Chronic Knee Pain with Noninvasive Peripheral Nerve Stimulation Using Novel Interferential RadioFrequencies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-10-10

Brief Summary

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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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Detailed Description

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1. Subject will perform screening and informed consent
2. Baseline measurements will be taken
3. Subject will sit in chair with back support throughout duration of the session
4. Knee for treatment will be verified and marked
5. Technician will wrap antenna applicator strap around the lower leg, at the knee
6. 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.
7. Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
8. At the end of 15 minutes, post-therapy measurements are recorded

Conditions

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Chronic Knee Pain Chronic Knee Osteoarthritis Post Surgical Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Recipient of Hypersound Therapy

Group Type EXPERIMENTAL

RF-PNS

Intervention Type DEVICE

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Interventions

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RF-PNS

Noninvasive peripheral nerve stimulator using interferential multi source radio frequency

Intervention Type DEVICE

Other Intervention Names

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Noninvasive PNS Hypersound

Eligibility Criteria

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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.