Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting - A Pragmatic, 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
- 248
- 试验地点
- 3
- 主要终点
- Change from baseline in BCTQ function status subscale at 6 weeks
研究概览
简要总结
The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.
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 unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;
- •Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study.
- •During the current episode, the target side has not been treated.
排除标准
- •Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
- •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 opioids.
- •Patients who have used opioids (e.g., tramadol) or neuropathic pain medications (gabapentin, pregabalin, etc.) 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;
- •Patients who are pregnant or plan to become pregnant within the next 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)
结局指标
主要结局
Change from baseline in BCTQ function status subscale at 6 weeks
时间窗: 0,6 weeks
Change from baseline in the score of the BCTQ function status subscale (Boston Carpal Tunnel Questionnaire Function Status Subscale) will be compared between treatment groups at 6 weeks follow-up.
Change from baseline in BCTQ symptom severity subscale at 6 weeks
时间窗: 0,6 weeks
Change from baseline in the score of the BCTQ symptom severity subscale (Boston Carpal Tunnel Questionnaire Symptom Severity subscale) will be compared between treatment groups at 6 weeks follow-up.
次要结局
- Change from baseline in BCTQ symptom severity subscale(0,12,18 weeks)
- Change from baseline in BCTQ function status subscale(0,12,18 weeks)
- Change from baseline of EQ-VAS(0,6,12,18 weeks)
- Change from baseline of PSQI(0,6,12,18 weeks)
- Change from baseline of the cross-sectional area of the median nerve(0,18 weeks)
- Surgical rate within 18 weeks(18 weeks)
研究者
Yun Qian
Principal Investigator
Shanghai 6th People's Hospital