NCT05497037已完成不适用
A Prospective, Multicenter, Randomized, Double-Blind, Two-Arm, Sham-Controlled, Parallel-Design Trial to Assess the Efficacy and Safety of Carpal Stim for Treating Carpal Tunnel Syndrome
GiMer Medical5 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 20 years old during the recruitment phase
- •Clinical diagnosis of CTS：
- •Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
- •Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase
- •Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
- •The subject is willing and able to comply with the procedure and requirements of this trial
- •The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements
排除标准
- •Wrist fractures or cysts at the CTS affected side
- •Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
- •Receiving upper limb (including neck) surgery
- •Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
- •With a past medical history of diabetic polyneuropathy
- •With a past medical history of rheumatoid arthritis
- •With a past medical history of epilepsy
- •Body Mass Index (BMI) > 40 kg/m2
- •Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
- •Active infection at the stimulator contact site during the recruitment phase
- •Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
- •Patients with implanted medical devices that are electronic products, such as implantable cardioverter defibrillators, pacemakers, spinal cord stimulation systems, or spinal cord drug infusion pumps
结局指标
主要结局
Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
时间窗: Up to 14 days
Effectiveness: The responder rate of the PRF group and Sham-Control group
时间窗: 1 hour after end of stimulation
Safety: Change in Nerve Conduction Velocity 14th day compared to baseline
时间窗: 14 days
Median nerve sensory latency time change over 20%
次要结局
- Change in PGIC scale in treatment and sham-controlled compared to baseline(1hr, 3, 7, 14 days after end of stimulation)
- Proportion in responder in treatment and sham-controlled groups(3, 7, 14 days after end of stimulation)
- Change in NRS score in treatment and sham-controlled groups compared to baseline(1hr, 3, 7, 14 days after end of stimulation)
- Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline(14 days after end of stimulation)
- Change in GSS score in treatment and sham-controlled compared to baseline(1hr, 3, 7, 14 days after end of stimulation)
- Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline(14 days after end of stimulation)
研究者
研究点 (5)
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