Chronic Knee PainEarly Phase 1NCT06626854
Treating Chronic Pain of Peripheral Nerve Origin With the Novel Noninvasive Hypersound Neuromodulation System
A Early Phase 1 study testing RF-PNS in people with Chronic Knee Pain and Chronic Knee Osteoarthritis, run by Hypersound Medical Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Knee Pain, Chronic Knee Osteoarthritis, Post Surgical Neuropathic Pain
- What is being tested?
- RF-PNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to 10 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Existing Peripheral Nerve Stimulator Implant in the lower extremities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
- 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
- Being tested
- RF-PNS
- Keywords
- rfPNS, Hypersound, Neuroharmonix, Noninvasive PNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF-PNSDevice
Also called Noninvasive PNS, Hypersound
Noninvasive peripheral nerve stimulator using interferential multi source radio frequency
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Recipient of Hypersound Therapy Receives: Device: RF-PNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analog Score Improvement of 50%
Measured: 3 months
Secondary outcomes (1)
Disability
Oswestry disability index improvement of greater than 50%
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Jun 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hypersound Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626854
- Sponsor's protocol ID
- HMI01
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Staff and research team aren't supported to persist the data
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06626854
- Acronym / sponsor ID
- HMI01
- Keywords
- rfPNS, Hypersound, Neuroharmonix, Noninvasive PNS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hypersound Medical IncIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: RF-PNSRecipient of Hypersound Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Existing Peripheral Nerve Stimulator Implant in the lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF-PNSAlso: Noninvasive PNS, HypersoundNoninvasive peripheral nerve stimulator using interferential multi source radio frequency | Device | Treatment |
Primary outcome
VAS
Time frame: 3 months
Visual Analog Score Improvement of 50%
1 secondary outcome
Disability
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Staff and research team aren't supported to persist the data
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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
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Medication vs. Meditation for Chronic Knee Osteoarthritis
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RF-PNS in people with Chronic Knee Pain and Chronic Knee Osteoarthritis, run by Hypersound Medical Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Dickman, MS ((480) 278-9200, timd@hypersoundmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.