Mild Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981565
• Other study ID #: NKCH-Surg-005
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: October 17, 2012
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: North Karelia Central Hospital, clinic of surgery
• Study type: Interventional

Clinical Trial Summary

Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative and surgical treatment options have been described.

Studies of surgical versus conservative treatment in mild carpal tunnel syndrome have not been done and it is still unclear whether or not surgical treatment is better than conservative treatment.

The aim of this study is to research has surgery better outcome in mild CTS than conservative treatment. Patient satisfactory, clinical and electrophysiologic outcomes, direct and indirect costs will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• electrophysiologically proven minimal or mild CTS lasting more than six months will be included in this study

Exclusion Criteria:

• rheumatoid arthritis

• diabetes mellitus

• hypothyreosis

• pregnancy

• wrist trauma or previous surgery

• splinting or corticosteroid injection on the affected side

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• open carpal tunnel release
surgery to release the carpal tunnel

Other:
• Night-cast
individual night time splinting

Locations

Country	Name	City	State
Finland	North-Carelia Central Hospital	Joensuu
Finland	Kuopio University Hospital	Kuopio
Finland	Central Hospital of Mikkeli	Mikkeli

Sponsors (1)

Lead Sponsor	Collaborator
North Karelia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Symptom Severity Score		1 year	No
Primary	Pain Visual Analogue Scale (VAS)		1 year	No
Secondary	Change in electroneuromyography		1 year	No