Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- BCTQ SSS at 8 Weeks vs Baseline
研究概览
简要总结
Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.
详细描述
It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment.
This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12).
There are two study groups: the active device group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
- •CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit
- •CTS severity determined via AANEM criteria 13
- •Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist)
- •BCTQ SSS > 2
- •Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets
- •Willing to abstain from any other treatment or therapies for CTS throughout the study
- •Ability to read and write English, or has a reliable person to assist with reading and writing English
排除标准
- •Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
- •Double crush syndrome
- •Cervical stenosis
- •Brachial plexopathy
- •Wrist fractures or cysts
- •Prior wrist surgeries, especially carpal tunnel release surgery
- •Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months
- •Thyroid disease
- •Rheumatoid arthritis
- •Systemic diseases
- •Connective tissue diseases
- •Fibromyalgia or chronic pain syndrome
- •Diabetic neuropathy
- •Participation in other research studies or clinical trials currently or within the past 2 weeks.
- •To assess eligibility, visit: carpaltunneltrial.com
结局指标
主要结局
BCTQ SSS at 8 Weeks vs Baseline
时间窗: baseline and 8 weeks post-Baseline
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms).
次要结局
- BCTQ SSS(8-weeks post-Baseline and 12 weeks post-Baseline)