A Randomized, Participant-Blinded, Sham-Controlled Study of Noninvasive Hypersound Radiofrequency Neuromodulation for Chronic Neuropathic and Radicular Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to treatment assignment. The device operator may know assignment. Blinded outcome assessment and statistical analysis will be used where feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Hypersound
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.
干预措施: Hypersound RF-PNS system (Device)
Sham Hypersound
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.
干预措施: Sham Hypersound (Device)
结局指标
主要结局
Percentage of Participants Achieving at Least a 50% Reduction in Average Pain Intensity
时间窗: 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.
次要结局
- Change From Baseline in Average 24-Hour Pain Intensity on the 100-mm VAS(Baseline and 90 days after the first treatment)
- Percentage of Participants Achieving at Least a 30% Reduction in Average Pain Intensity(Baseline and 90 days after the first treatment)
- Percentage of Participants Experiencing Adverse Events(First treatment through 90 days after the first treatment; for participants who cross over, first active treatment through 90 days after that treatment)