Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The CTS symptom severity score after treatment.
研究概览
简要总结
The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary, idiopathic CTS
- •Age 18-70 years, either gender
- •Symptom duration of at least 3 months and inadequate response to wrist splint
- •Symptoms of classic or probable CTS according to the diagnostic criteria in Katz hand diagram
- •Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS.
- •Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery)exclusion criteria
排除标准
- •Previous steroid injection for CTS in the same wrist
- •Inflammatory joint disease, diabetes mellitus· Vibration-induced neuropathy, polyneuropathy
- •Pregnancy
- •Trauma to the affected hand in the previous year
- •Previous CTS surgery in the affected hand
- •Inability to complete questionnaires due to language problem or cognitive disorder
- •Severe medical illness
- •Known abuse of drugs and/or alcohol
研究组 & 干预措施
A
干预措施: Methylprednisolone 40 mg (Drug)
B
干预措施: Methylprednisolone 80 mg (Drug)
C
干预措施: Sodium chloride (Drug)
结局指标
主要结局
The CTS symptom severity score after treatment.
时间窗: 10 weeks
Rate of surgery
时间窗: 52 weeks
次要结局
- The CTS symptom severity score after treatment(52 weeks)
- Time to surgery(52 weeks)
- QuickDASH score(52 weeks)
- SF-6D score(52 weeks)
- Patient satisfaction with the results of treatment (VAS scale)(52 weeks)
- Registration of adverse events(24 weeks)