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NCT Number: NCT07831447

Hypersound Treatment for Chronic Neuropathic and Radicular Pain

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.

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Key information

Conditions

Chronic Neuropathic Pain Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathic Pain Radiculopathy Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Pain and Supportive Care

Phoenix, Arizona, 85028, United States

About this study

This prospective, randomized, participant-blinded, sham-controlled investigation evaluates the safety and preliminary efficacy of noninvasive Hypersound radiofrequency peripheral nerve stimulation in adults with chronic neuropathic or radicular pain, including lumbosacral radicular pain and peripheral neuropathic pain affecting the upper or lower extremities. Enrollment will follow completion of the applicable UG3 engineering, safety, and clinical-readiness milestones.

The study targets approximately 60 evaluable participants from 71 enrolled participants. Active treatment uses multiple external antennas and a prospectively defined fluctuating-stimulation algorithm within verified operating limits. Sham treatment resembles active treatment in positioning, antenna placement, duration, visit schedule, and interactions with personnel, without delivering the intended therapeutic exposure. Participants are blinded; operators may know assignment, with blinded outcome assessment and statistical analysis where feasible.

After the randomized 90-day assessment, participants initially assigned to sham are offered active treatment. Post-crossover outcomes are analyzed separately. Supportive analyses will examine perceived nerve stimulation and its relationship to pain response. Prior feasibility observations of perceived stimulation do not establish analgesic efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Clinically confirmed chronic neuropathic or radicular pain of at least three months' duration.
  • An identifiable anatomical treatment target.
  • Baseline pain meeting the minimum intensity threshold specified in the protocol.
  • Stable pain-treatment regimen as defined in the protocol.
  • Able to provide informed consent and to complete patient-reported assessments.
  • Willing to complete the treatment course and follow-up visits.

Exclusion criteria

  • Unstable medical or neurological disease.
  • Another dominant source of pain that would interfere with evaluation of the target pain condition.
  • Inability to reliably report outcomes.
  • Contraindications to the investigational device as specified in the protocol.
  • Major recent changes in pain treatment, as defined in the protocol.
  • Participation in another intervention likely to materially affect study outcomes.

Treatment and study plan

Hypersound RF-PNS system

Device

A nonimplantable system that uses multiple externally positioned antennas to deliver controlled radiofrequency energy intended to stimulate peripheral nerves. Participants receive ten 15-minute sessions, twice weekly over five weeks, with antennas positioned for the participant's identified anatomical treatment target. Treatment uses the final verified system and the prospectively defined fluctuating-stimulation algorithm within established operating limits. Numerical treatment settings and the final algorithm are to be specified in the protocol.

Other names: Noninvasive peripheral nerve stimulator

Sham Hypersound

Device

Sham use of the Hypersound system. Sessions match active treatment in positioning, antenna placement, session length, visit schedule, and interaction with study personnel, but do not deliver the intended therapeutic Hypersound exposure. Participants receive ten 15-minute sham sessions, twice weekly over five weeks. The exact sham operating method is to be finalized in the protocol. After the 90-day primary assessment, participants are offered the active treatment course.

Primary outcomes

  1. Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity

    Time frame: Baseline and 90 days after the first treatment

    Pain intensity is assessed with a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. Participants rate their average pain during the preceding 24 hours. Baseline is assessed before the first treatment. A responder is a participant whose VAS score decreases by at least 50% from baseline at the 90-day assessment. The percentage of responders is compared between the randomized active Hypersound and sham groups.

Secondary outcomes

  1. Change From Baseline in Average 24-Hour Pain Intensity on the 100-mm VAS

    Time frame: Baseline and 90 days after the first treatment

    Average pain intensity over the preceding 24 hours is rated on a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. Change is calculated as the day-90 score minus the baseline score, so negative values indicate improvement.

  2. Percentage of Participants Achieving at Least a 30% Reduction in Average Pain Intensity

    Time frame: Baseline and 90 days after the first treatment

    Average pain intensity over the preceding 24 hours is rated on a 100-mm visual analog scale (VAS) ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with lower scores indicating less pain. A responder is a participant whose VAS score decreases by at least 30% from baseline at the 90-day assessment.

  3. Percentage of Participants Experiencing Adverse Events

    Time frame: First treatment through 90 days after the first treatment; for participants who cross over, first active treatment through 90 days after that treatment

    Adverse events are collected and characterized by severity, seriousness, expectedness, and relationship to the device or to study treatment. Events occurring during the randomized period are summarized separately from events occurring after crossover to active treatment.

Other outcomes

  1. Percentage of Participants Reporting Perceived Nerve Stimulation During Treatment

    Time frame: During the five-week treatment course

    Participants are asked whether they perceived nerve stimulation during treatment sessions. The exact wording of the question and the method of aggregating responses across the ten sessions will be specified in the final protocol. Results support exploratory analyses of the relationship between perceived stimulation and pain response.

  2. Percentage of Participants Reporting Each Belief About Their Assigned Treatment

    Time frame: At the 90-day assessment, before disclosure of treatment assignment

    Participants are asked which treatment they believe they received, with response options of active, sham, or uncertain. This measure assesses the success of participant blinding and is collected before treatment assignment is disclosed.

Study contacts

Contact information is provided by the study sponsor or research team.

Tim Dickman

CONTACT

[email protected]

480-278-9200

Sponsors and collaborators

Lead sponsor

Hypersound Medical Inc

Industry

Registry information

Official study title

A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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