Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: Protocol of a randomized double-blind placebo-controlled trial (NCT 00806871)

BMC Musculoskeletal Disorders

Study Protocol

Jonas Björk¹  Magnus Flondell²  Isam Atroshi²  Manfred Hofer³ 

[1] Competence Centre for Clinical Research, Lund University Hospital, SE-22185, Lund, Sweden;Department of Orthopedics, Hässleholm and Kristianstad Hospitals, SE-28125, Hässleholm, Sweden;Department of Clinical Sciences, Lund University, SE-22100, Lund, Sweden;Department of Physiotherapy, Kristianstad Hospital, SE-29185, Kristianstad, Sweden;

关键词: Carpal Tunnel Syndrome;    Carpal Tunnel;    Steroid Injection;    Orthopedic Department;    Carpal Tunnel Release;   

DOI  :  10.1186/1471-2474-11-76

 received in 2010-01-07, accepted in 2010-04-21,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPatients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.Methods/DesignThe study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, Quick DASH and SF-6D), adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in Quick DASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures.DiscussionThis paper describes the rationale and design of a double-blind, randomized placebo-controlled trial that aims to determine the efficacy of two different doses of steroid injected into the carpal tunnel in patients with moderately severe idiopathic CTS.Trial registrationClinicaltrials.gov identifier NCT00806871

【 授权许可】

CC BY   
© Flondell et al; licensee BioMed Central Ltd. 2010