Comparison of Corticosteroid Injection, Nighttime Splinting, or Their Combination for Initial Treatment of Moderate-to-Severe Carpal Tunnel Syndrome: A Pragmatic, Three-Armed, Open-Label, Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 318
- 试验地点
- 3
- 主要终点
- Surgical rate within 52 weeks
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of corticosteroid injection, night splinting, and their combined use as initial treatments for adults with moderate to severe carpal tunnel syndrome (CTS), and to assess the safety and tolerability of these interventions. The primary research questions include:
- Doe corticosteroid injection, night splinting, and their combined use as initial treatments reduce the need for surgery in participants with moderate to severe CTS?
- How do these interventions affect the improvement of patient symptoms?
Participants will:
- Receive corticosteroid injection, night splinting, or their combination as initial treatments.
- Visit the clinic once every 6 weeks over a period of one year for assessments and dynamic adjustment of the treatment plan.
- Undergo periodic assessments of wrist function, quality of life, and sleep quality using standardized questionnaires.
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
- None
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
- •Patients aged no less than 18 years old with idiopathic carpal tunnel syndrome of the target side diagnosed by a specialist according to the Katz diagnostic criteria;
- •The current episode has occurred within 6 weeks without treatment before eligibility assessment, and the target side has moderate-to-severe symptoms.
排除标准
- •Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- •Any secodary CTS caused by comorbid diseases, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, CPPD (calcium pyrophosphate dihydrate deposition disease), etc.;
- •History of fracture or surgery on the target side of the wrist;
- •Bilateral CTS with moderate or severe symptoms in both hands;
- •Received corticosteroid injections in the wrist within the past 6 months;
- •Patients who are unable to wear a splint due to trauma or other reasons;
- •Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
- •Patients who require long-term use of any form of analgesic medication, such as NSAIDs (nonsteroidal anti-inflammatory drugs), opioids, acetaminophen, etc.;
- •Patients who have used NSAIDs, opioids (e.g., tramadol), neuropathic pain medications (gabapentin, pregabalin, etc.), or oral corticosteroids within the past 2 weeks;
- •Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months;
- •Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months.
研究组 & 干预措施
Nighttime splinting
Wear a wrist neutral position splint at night for 6 weeks as the initial treatment.
干预措施: Nighttime Splinting (Device)
Nighttime splinting
Wear a wrist neutral position splint at night for 6 weeks as the initial treatment.
干预措施: Evaluation and Dynamic Adjustment (Other)
Corticosteroid injection
Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
干预措施: Corticosteroid Injection (Drug)
Corticosteroid injection
Local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
干预措施: Evaluation and Dynamic Adjustment (Other)
Combination
Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
干预措施: Nighttime Splinting (Device)
Combination
Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
干预措施: Corticosteroid Injection (Drug)
Combination
Nighttime splinting for 6 weeks combined with local corticosteroid injection (triamcinolone acetonide 40mg) as the initial treatment.
干预措施: Evaluation and Dynamic Adjustment (Other)
结局指标
主要结局
Surgical rate within 52 weeks
时间窗: 52 weeks
Participants will be asked if they have undergone surgery for carpal tunnel syndrome in the last 52 weeks.
次要结局
- Change from baseline in BCTQ symptom severity subscale(0,6,12,24,52 weeks)
- Change from baseline in BCTQ function status subscale(0,6,12,24,52 weeks)
- Change from baseline of EQ-VAS(0,6,12,24,52 weeks)
- Change from baseline of PSQI(0,6,12,24,52 weeks)
- Change from baseline of the cross-sectional area of the median nerve(0,52 weeks)
- The incidence rate of clinical and electrophysiological changes indicative of new-onset axonal loss or denervation within 52 weeks(52 weeks)
研究者
Yun Qian
Principal Investigator
Shanghai 6th People's Hospital