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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
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.
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.
Center for Pain and Supportive Care
Phoenix, Arizona, United States
Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity
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.
Time frame: Baseline and 90 days after the first treatment
Change From Baseline in Average 24-Hour Pain Intensity on the 100-mm VAS
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.
Time frame: Baseline and 90 days after the first treatment
Percentage of Participants Achieving at Least a 30% Reduction in Average Pain Intensity
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.
Time frame: Baseline and 90 days after the first treatment
Percentage of Participants Experiencing Adverse Events
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.
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
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