ocal steroid injection in the treatment of idiopathic carpal tunnel syndrome: A randomized double-blind placebo-controlled trial among patients planned for surgical treatment - steroid injection treatment of CTS

Conditions: eurography verified Carpal tunnel syndrome
MedDRA version: 9.1Level: LLTClassification code 10007697Term: Carpal tunnel syndrome
MedDRA version: 9.1Level: LLTClassification code 10050127Term: Electroneurography

Registration Number: EUCTR2008-001871-31-SE

Lead Sponsor: Region skåne- Hässleholms sjukvårdsorganisation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

·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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for 10 weeks with outcomes measured with valid standardized outcome instruments.<br>To evaluate rate of surgery at 52,24,12 weeks;Secondary Objective: To assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 52 weeks with outcomes measured with valid standardized outcome instruments.<br><br>To assess safety of injecting steroid into the carpal tunnel, AE recording during 6 months after periarticular injection;Primary end point(s): Primary endpoint<br><br>1.-The score change on the validated CTS symptom severity scale at 10 weeks after treatment.<br> Comparing:<br>1.high dose vs placebo<br>2.low dose vs placebo<br>3.high dose vs low dose<br><br>2.-Rate of surgery in rank order 52,24,12 weeks after treatment<br>Comparing:<br>1.high dose vs placebo<br>2.low dose vs placebo<br>3.high dose vs low dose<br>

Secondary Outcome Measures