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Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment

This study is currently Recruiting

March 2011 By Region Skane

First Recieved on December 10, 2008

Last Updated on March 24, 2011

Sponsor: Region Skane
Collaborators:
Information provided by: Region Skane
Identifier: NCT00806871

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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)exclusion criteria 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

Investigators

  • Investigator: Isam Atroshi, MD, PhD - Study Chair - Lund university, department of clinical sciences, H?ssleholm hospital, department of orthopedics

Locations

  • Ortopediska kliniken, sjukv?rdsorganisationen H?ssleholm/CSK

    H?ssleholm, 281 25 Sweden

Conditions related to this trial:

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