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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
  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: 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:

U.S. FDA Resources

Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change in electroneuromyography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT00981565     History of Changes
Other Study ID Numbers: NKCH-Surg-005
Study First Received: September 11, 2009
Last Updated: October 17, 2012
Health Authority: Finland: North Karelia Central Hospital, clinic of surgery

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

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

ClinicalTrials.gov processed this record on May 23, 2013