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Mild Carpal Tunnel Syndrome

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. Identifier: NCT00981565
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: open carpal tunnel release Other: Night-cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Active Comparator: Operative Procedure: open carpal tunnel release
surgery to release the carpal tunnel

Active Comparator: Conservative Other: Night-cast
individual night time splinting

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00981565

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North-Carelia Central Hospital
Joensuu, Finland
Kuopio University Hospital
Kuopio, Finland
Central Hospital of Mikkeli
Mikkeli, Finland
Sponsors and Collaborators
North Karelia Central Hospital
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Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital Identifier: NCT00981565    
Other Study ID Numbers: NKCH-Surg-005
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012
Keywords provided by Sanna Kouhia, North Karelia Central Hospital:
Carpal tunnel syndrome
medianus impingement
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries