IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome (IMPACTS): A Single-Centre, Randomized Trial Comparing Perineural Hydrodissection of the Median Nerve Versus Steroid Injection in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Boston Carpal Tunnel Questionnaire (BCTQ)
研究概览
简要总结
This is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. Patients are followed at 6-week, 3-month, 6-month, and 12-month time points to assess the primary and secondary outcomes of the study, which include both patient-reported outcome measures and objective clinical assessments.
详细描述
This study aims to examine the effect of perineural hydrodissection (PNH), a novel treatment for CTS. PNH is a minimally invasive, ultrasound-guided, percutaneous technique in which the median nerve is released by injecting fluid (local anesthetic and corticosteroid) circumferentially, using larger fluid volumes and higher pressure to target areas of adhesion between the median nerve and its surrounding structures. In chronic CTS, a rind of perineural fibrosis develops, tethering the median nerve to the overlying flexor retinaculum and to the adjacent flexor tendons. Theoretically, the removal of tethering to adjacent structures, via perineural hydrodissection, should allow circumferential bathing of the median nerve with the local anesthetic and corticosteroid, thus reducing inflammation and prolonging symptom relief.
The primary outcome is pain as measured by the Boston Carpal Tunnel Questionnaire (BCTQ). Secondary outcomes include health-related quality of life measures using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Visual Analog Scale (VAS) for pain.
The selected questionnaires have been shown to correlate well with domains of the International Classification of Functioning, Disability, and Health (ICF) (3). Other secondary measures include the ultrasound appearance (cross-sectional index) of the median nerve, and electromyography (EMG) measurements (including sensory and motor conduction velocities, and amplitudes), before and after the injection.
The study hypothesis is that PNH will show greater benefits in terms of pain, function, and patient quality of life when compared to corticosteroid injection in patients with CTS. The null hypothesis is that there is no difference. The study is powered to address the primary outcome and will also be powered to identify minimally important differences in functional, sonographic, and electromyographic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Care provider is performing a specific type of injection and therefore cannot be blinded. Those investigators responsible for collecting, managing, and analyzing data will be blinded to treatment randomization.
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
- •Adult men or women aged 18 years or greater.
- •Clinical and electromyographic diagnosis of Carpal Tunnel Syndrome.
- •Persistent symptoms from Carpal Tunnel Syndrome after at least three months of appropriate splinting.
- •Ability to consent for study.
排除标准
- •Acute symptom onset (less than 3 months).
- •Bifid median nerve
- •Anticoagulation with International Normalized Ratio (INR) > 1.4, or platelets <
- •Anomalous muscles (eg. inverted palmaris longus).
- •Patients requiring anti-platelet medication for the treatment of heart attack, stroke, or other medical condition.
- •Previous surgery for Carpal Tunnel Syndrome.
- •Previous local injections, including steroids within the past 6 months.
- •Allergy to any of the injection agents.
研究组 & 干预措施
Group 1: Corticosteroid Injection
Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.
干预措施: Corticosteroid Injection (Procedure)
Group 2: Perineural Hydrodissection
Patients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique.
干预措施: Perineural Hydrodissection (Procedure)
结局指标
主要结局
Change in Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: Baseline, 6 weeks, 3 months, 6 months, 1 year
The BCTQ is a five-point rating scale with 19 items. The overall score is the average score across all items. The score will be recorded for each visit and change in score will be plotted over time.
次要结局
- Change in Electromyographic Measurement- Motor Conduction Velocity(Baseline, 6 months, 1 year)
- Change in Visual Analog Scale (VAS) for Pain(Baseline, 6 weeks, 3 months, 6 months, 1 year)
- Change in Ultrasonographic Measurement(Baseline, 6 weeks, 6 months, 1 year)
- Change in Electromyographic Measurement- Amplitude(Baseline, 6 months, 1 year)
- Change in Electromyographic Measurement- Sensory Conduction Velocity(Baseline, 6 months, 1 year)
- Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(Baseline, 6 weeks, 3 months, 6 months, 1 year)
研究者
Leslie Witton
Neurology Resident
Hamilton Health Sciences Corporation