Systemic Versus Local Corticosteroids in the Treatment of Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Compare the Boston Carpal Tunnel Syndrome Questionnaire
研究概览
简要总结
The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.
The main questions it aims to answer are:
- What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?
- What are the adverse effects and application site pain associated with each route of administration?
Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.
The Redcap randomizer will be used to assign the patient to one of the branches.
Researchers will compare
- Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound
- Branch B: patients treated with intramuscular corticosteroid injection.
Researchers will:
- Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.
- Describe adverse reactions associated with the route of administration.
- Compare the pain at the site of application associated with the route of administration.
详细描述
Carpal tunnel syndrome (CTS) is the most common peripheral compressive neuropathy of the upper limb, consisting of involvement of the median nerve at the level of the carpal tunnel. It has a prevalence of 7% to 16% in the United Kingdom adult population, while in the United States between 400/500 thousand patients are treated surgically, with an annual economic cost exceeding $2 billion.
A variety of treatments are available according to the stage of the pathology, including splinting, kinesic therapy, ultrasound, non-steroidal anti-inflammatory drugs, systemic or local corticosteroids , as well as surgical treatment in patients who do not respond to previous options.
Corticosteroid infiltration is one of the most widely used methods for the treatment of idiopathic carpal tunnel syndrome (ICTS) in mild and moderate stages, and short-term symptomatic improvement is reported in the literature, although the optimal dose and drug used for the same is varied in the various published studies, and is still a matter of debate in the literature. Betamethasone has greater anti-inflammatory power and a longer duration of action at the same equivalent dose than other corticosteroids used in the treatment of CTS (prednisolone, methylprednisolone, triamcinolone, cortisone).
In addition, ultrasound-guided local infiltration helps prevent iatrogenic injury compared to anatomical repair-guided infiltration. Studies show improvement in scores assessing symptomatology, although there is no strength in determining improvement in functional and electromyographic assessment. The rate of adverse reactions with this technique is low, reported to be <0.1% for major complications, and 2% for minor complications.
The effectiveness of local and systemic corticosteroids has been demonstrated, but whether there is any difference in clinical improvement in patients between one route of administration versus the other remains a question mark.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older
- •Clinical diagnosis of mild/moderate idiopathic Carpal Tunnel Syndrome (paresthesias in the territory of the median nerve: in fingers 1, 2, 3 and radial border of 4 of the hand, nocturnal hand pain, and Positive Tinel's test, or Positive Phalen's test, or Positive Durkan's test)
- •Diagnosis by electromyography and sensory and motor conduction velocity of mild/moderate involvement
- •Patients who have agreed to participate in the study and signed the informed consent form.
排除标准
- •Cervical radiculopathy, polyneuropathy, brachial plexus pathologies, thoracic operculum syndrome
- •Systemic diseases causing secondary Carpal Tunnel Syndrome (rheumatoid arthritis, diabetes with polyneuropathy, hypothyroidism with low adherence to treatment, chronic renal disease)
- •Chronic corticosteroid therapy or regular use of non-steroidal anti-inflammatory drugs
- •Severe carpal tunnel syndrome: signs of thenar atrophy, daytime pain, sensory deficit in median nerve territory (two-point discrimination test >10mm)
- •Previous history of wrist or distal radius fracture
- •Corticosteroid allergies
- •Pregnancy
研究组 & 干预措施
Branch B: treated with intramuscular corticosteroid injection
One dose. 2 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6m/2ml.
干预措施: Systemic bethametasone injection (Procedure)
Branch A: Local corticosteroid infiltration under ultrasound
One dose. 1 ml Betamethasone acetate 6mg/2ml + Betamethasone disodium phosphate 6mg/2ml
干预措施: Local bethametasone injection (Procedure)
结局指标
主要结局
Compare the Boston Carpal Tunnel Syndrome Questionnaire
时间窗: 12 months
Compare the Boston Carpal Tunnel Syndrome Questionnaire in patients treated with systemic (intramuscular) versus local infiltration corticosteroids Two scales: * Symptom severity scale (11 questions): sum of the score of each question divided by the number of questions, with the lower limit and lower severity1 , and the upper limit and higher severity 5 * Functional status scale (8 questions): sum of the score of each question divided by the number of questions, with the lower limit and lower severity 1, and the upper limit and higher severity 5.
次要结局
- Adverse reactions(12 months)
- Pain at the site of application(12 months)
研究者
Jorge Guillermo Boretto
Principal Investigator
Hospital Italiano de Buenos Aires