Steroid Injection Treatment of Carpal Tunnel Syndrome

Phase 2

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Methylprednisolone 40 mg; Drug: Methylprednisolone 80 mg; Drug: Sodium chloride

• Registration Number: NCT00806871
• Lead Sponsor: Region Skane

Brief Summary

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.

Detailed Description

www.biomedcentral.com/1471-2474/11/76

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Status Verified: 2011-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Methylprednisolone 40 mg	-
B	Methylprednisolone 80 mg	-
C	Sodium chloride	-

Primary Outcome Measures

Name	Time	Method
The CTS symptom severity score after treatment.	10 weeks
Rate of surgery	52 weeks

Secondary Outcome Measures

Name	Time	Method
The CTS symptom severity score after treatment	52 weeks
Time to surgery	52 weeks
QuickDASH score	52 weeks
SF-6D score	52 weeks
Patient satisfaction with the results of treatment (VAS scale)	52 weeks
Registration of adverse events	24 weeks

Trial Locations

Locations (1)

Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK; 🇸🇪 Hässleholm, Sweden