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Mild Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981565
First Posted: September 22, 2009
Last Update Posted: October 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital
  Purpose

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.


Condition Intervention
Carpal Tunnel Syndrome Procedure: open carpal tunnel release Other: Night-cast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by Sanna Kouhia, North Karelia Central Hospital:

Primary Outcome Measures:
  • Change in Symptom Severity Score [ Time Frame: 1 year ]
  • Pain Visual Analogue Scale (VAS) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Change in electroneuromyography [ Time Frame: 1 year ]

Enrollment: 88
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operative Procedure: open carpal tunnel release
surgery to release the carpal tunnel
Active Comparator: Conservative Other: Night-cast
individual night time splinting

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981565


Locations
Finland
North-Carelia Central Hospital
Joensuu, Finland
Kuopio University Hospital
Kuopio, Finland
Central Hospital of Mikkeli
Mikkeli, Finland
Sponsors and Collaborators
North Karelia Central Hospital
  More Information

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT00981565     History of Changes
Other Study ID Numbers: NKCH-Surg-005
First Submitted: September 11, 2009
First Posted: September 22, 2009
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Sanna Kouhia, North Karelia Central Hospital:
Carpal tunnel syndrome
CTS
medianus impingement

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries