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Mild Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
open carpal tunnel release
Night-cast
Sponsored by
North Karelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, CTS, medianus impingement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North-Carelia Central Hospital
  • Kuopio University Hospital
  • Central Hospital of Mikkeli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Operative

Conservative

Arm Description

Outcomes

Primary Outcome Measures

Change in Symptom Severity Score
Pain Visual Analogue Scale (VAS)

Secondary Outcome Measures

Change in electroneuromyography

Full Information

First Posted
September 11, 2009
Last Updated
October 17, 2012
Sponsor
North Karelia Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00981565
Brief Title
Mild Carpal Tunnel Syndrome
Official Title
Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome, CTS, medianus impingement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Active Comparator
Arm Title
Conservative
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
open carpal tunnel release
Intervention Description
surgery to release the carpal tunnel
Intervention Type
Other
Intervention Name(s)
Night-cast
Intervention Description
individual night time splinting
Primary Outcome Measure Information:
Title
Change in Symptom Severity Score
Time Frame
1 year
Title
Pain Visual Analogue Scale (VAS)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in electroneuromyography
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
North-Carelia Central Hospital
City
Joensuu
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Central Hospital of Mikkeli
City
Mikkeli
Country
Finland

12. IPD Sharing Statement

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Mild Carpal Tunnel Syndrome

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