Mild Carpal Tunnel Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanna Kouhia, North Karelia Central Hospital

ClinicalTrials.gov Identifier:

NCT00981565

First received: September 11, 2009

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 11, 2009
Last Updated Date	October 17, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 21, 2009)	Change in Symptom Severity Score [ Time Frame: 1 year ] [ Designated as safety issue: No ] Pain Visual Analogue Scale (VAS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00981565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 21, 2009)	Change in electroneuromyography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mild Carpal Tunnel Syndrome
Official Title ^ICMJE	Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Carpal Tunnel Syndrome
Intervention ^ICMJE	Procedure: open carpal tunnel release surgery to release the carpal tunnel Other: Night-cast individual night time splinting
Study Arm (s)	Active Comparator: Operative Intervention: Procedure: open carpal tunnel release Active Comparator: Conservative Intervention: Other: Night-cast
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	88
Completion Date	June 2012
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT00981565
Other Study ID Numbers ^ICMJE	NKCH-Surg-005
Has Data Monitoring Committee	Not Provided
Responsible Party	Sanna Kouhia, North Karelia Central Hospital
Study Sponsor ^ICMJE	North Karelia Central Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	North Karelia Central Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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