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

Early Phase 1

Not yet recruiting

• Conditions: Chronic Knee Pain; Chronic Knee Osteoarthritis; Post Surgical Neuropathic Pain
• Interventions: Device: RF-PNS

• Registration Number: NCT06626854
• Lead Sponsor: Hypersound Medical Inc

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2026-01-10
• Primary Completion: 2026-08-10
• Study Completion: 2026-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	RF-PNS	Recipient of Hypersound Therapy

Primary Outcome Measures

Name	Time	Method
VAS	3 months	Visual Analog Score Improvement of 50%

Secondary Outcome Measures

Name	Time	Method
Disability	3 months	Oswestry disability index improvement of greater than 50%