Mild Carpal Tunnel Syndrome

Verified by: North Carelia Central Hospital, November 2010
First Received: September 11, 2009 | Last Updated: November 19, 2010 | Phase: N/A | Start Date: September 2009
Overall Status: Recruiting | Estimated Enrollment: 88
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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...

Brief Summary

Official Title: “Operative Versus Conservative Treatment in Mild Carpal Tunnel Syndrome, Randomized Prospective Multicenter Study”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2012

Intervention(s) in this Clinical Trial

  • Procedure: open carpal tunnel release
    • surgery to release the carpal tunnel
  • Other: Night-cast
    • individual night time splinting

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Operative
  • Active Comparator: Conservative

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in Symptom Severity Score
    • Time Frame: 1 year
      Safety Issue?: No
  • Pain Visual Analogue Scale (VAS)
    • Time Frame: 1 year
      Safety Issue?: No

Secondary Measures

  • Change in electroneuromyography
    • Time Frame: 1 year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: North Carelia Central Hospital Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Eppu Sainio, M.D. +358407763084 eppu.sainio@pkssk.fi

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00981565

Study ID Number: NKCH-Surg-005

ClinicalTrials.gov Identifier: NCT00981565

Health Authority: Finland: North Karelia Central Hospital, clinic of surgery

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00981565