Non-surgical Treatment of Carpal Tunnel Syndrome: Night Splint Versus Local Corticosteroid Infiltration: Clinical Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Remission of symptoms
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common neuropathic compression syndrome of the upper limbs, caused by compression of the median nerve in the wrist. There is no gold standard for establishing the diagnosis of STC. The diagnosis can be based on clinical findings and electrodiagnostic tests. Treatment options can be divided into surgical and non-surgical procedures. Surgical interventions include open carpal tunnel release, mini incision or release of the endoscopic carpal tunnel. Nonsurgical include daily activities modification, oral anti-inflammatory drugs (NSAIDs), oral corticosteroids, splints, corticosteroid injections or other options (laser therapy, ultrasound or acupuncture)
The aim of this study is to compare randomly, conservative treatment for CTS with night splint of the wrist versus local infiltration of corticosteroids after a min-imum period of six months follow-up.
Patients will be divided into two groups: night orthesis group that will receive the prescription to purchase the orthesis and guide the use of it; and infiltration group of patients will be referred to the Moema Alvorada Hospital to carry out infiltration. These patients will be evaluated before application, one week, one month, three months and six months after intervention.
详细描述
This study will be developed in the service of medical residency of surgery and microsurgery of the hand of Alvorada hospital (São Paulo - SP).
The Study Design is Randomized clinical trial according to the CONSORT STATEMENT (http://www.consort-statement.org) standards.
The number of participants will initially be 84 patients.
Inclusion criteria:
Adult patients 40 years of age or older with four or more of the following clinical signs and symptoms suggested by Graham et al. (CTS-6):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 40 years or more,
- •Have the diagnosis confirmed with electromyography (EMG),
- •Four or more than six of the following clinical signs and symptoms suggested by Graham et al (CTS-6):
- •Paraesthesia in the territory of the median nerve.
- •Night hand paresthesia
- •Atrophy of thenar muscles
- •Positive Tinel Sign
- •Phalen Test Positive
- •Loss of two point discrimination
- •Sign a Research Ethics Committe, after reading and explanation of the proposed study.
- •Non-inclusion criteria:
- •Pretreatment with corticosteroids and splint
- •Prior surgical treatment
- •Traumatic or nontraumatic pathologies associated
- •Hypersensitivity to corticosteroids
- •CTS secondary to other pathology
- •Refusal to sign a Research Ethics Committe.
- •Fixed Paresthesia
排除标准
- 未提供
研究组 & 干预措施
Carpal tunnel injection
Carpal tunnel injection (infiltration) group of patients will be referred to the Hospital Alvorada to carry out steroid injection. The injection in carpal tunnel will be an association of 6.43 mg of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate and 0.5 ml plus lidocaine 2%, totaling 1.5 ml.
干预措施: betamethasone dipropionate, betamethasone disodium phosphate and lidocaine 2% (Drug)
Wrist splinting
Wrist splinting will be use in the nigth time, remain the wrist in the 15th degree in extension, until its removal in the morning.
干预措施: Wrist splinting (Device)
结局指标
主要结局
Remission of symptoms
时间窗: 6 months
Remission of nocturnal paresthesia referred by the patient at six months the follow up.
Boston Questionnaire (Levine)
时间窗: 6 months
A questionnaire developed for the purpose of evaluating the severity of symptoms and the degree of manual ability of patients with CTS.
次要结局
- Graham Criteria - CTS-6(6 months)
- Visual Analogue Scale - EVA Pain Evaluation(6 months)
研究者
João Carlos Belloti
Clinical Professor
Hospital Alvorada