Hypersound Treatment for Neuropathic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate whether the investigational Hypersound system reduces pain in adults with chronic neuropathic or radicular pain. Hypersound uses externally positioned antennas to deliver radiofrequency energy intended to stimulate peripheral nerves without an implant. Approximately 71 participants will be randomly assigned in a two-to-one ratio to active Hypersound or sham treatment. Treatment consists of ten 15-minute sessions, twice weekly over five weeks. Participants will be unaware of their assigned treatment. The main comparison is the percentage of participants with at least a 50% decrease in average pain intensity at 90 days after the first treatment. Pain will be measured using a 100-mm visual analog scale referring to average pain over the preceding 24 hours. Safety and additional measures of pain and daily functioning will also be assessed. Participants initially assigned to sham will be offered active treatment after the 90-day assessment and followed for another 90 days after their first active treatment.
Are You a Good Fit for This Trial?
This trial is for adults with chronic nerve-related pain, such as sciatica or radiculopathy. Participants should have ongoing pain and be able to attend treatment sessions over five weeks.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Hypersound RF-PNS system
Trial Overview
The study tests a new Hypersound system that uses radio waves through the skin to stimulate nerves and reduce pain, compared to a sham (inactive) treatment. Sessions last 15 minutes, twice weekly for five weeks. Participants are randomly assigned and do not know which group they are in.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Ten 15-minute sessions of active Hypersound radiofrequency peripheral nerve stimulation, twice weekly over five weeks. External antennas are positioned for the identified anatomical treatment target. Treatment uses the final verified system and prospectively defined fluctuating-stimulation algorithm within established operating limits.
Participants undergo a procedure resembling active treatment, including comparable positioning, antenna placement, device and personnel interaction, and ten 15-minute sessions twice weekly over five weeks, without the intended therapeutic Hypersound exposure. After the 90-day primary assessment, participants are offered active treatment and are followed for 90 days after their first active treatment.
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Who Is Running the Clinical Trial?
Hypersound Medical Inc
Lead Sponsor
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