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Mild Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT00981565
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : October 18, 2012
Sponsor:
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
Carpal Tunnel Syndrome Procedure: open carpal tunnel release Other: Night-cast

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
Primary Completion Date : September 2011
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 ]


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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

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

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT00981565     History of Changes
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
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