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Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment (CTS)

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ClinicalTrials.gov Identifier: NCT00694265
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : August 26, 2008
Sponsor:
Information provided by:
University of Bern

Brief Summary:
In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Procedure: Decompression Procedure: Conservative treatment

Detailed Description:

Objective:

In wrists with carpal tunnel syndrome (CTS) the sonographically measured largest cross-sectional area (CSA) of the median nerve is increased. We compared the changes in largest CSA in wrists undergoing surgical decompression and wrists undergoing conservative treatment of CTS.

Methods:

Prospective cohort study in 55 consecutive patients with 78 wrists with established CTS, including 60 wrists with surgical decompression and 18 wrists with conservative treatment. A sonographic examination was scheduled before and at 4 months after initiation of treatment. Changes in CSA between wrists with surgical and wrists with conservative treatment were compared using linear regression models.


Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment: Prospective Cohort Study.
Study Start Date : January 2002
Primary Completion Date : June 2003
Study Completion Date : December 2003


Group/Cohort Intervention/treatment
1
Surgical treatment
Procedure: Decompression
Surgical decompression of the median nerve
2
Conservative treatment
Procedure: Conservative treatment
Conservative treatment typically consisted of splinting and corticosteroid injections



Primary Outcome Measures :
  1. Measure of the largest cross-sectional area (CSA) of the median nerve [ Time Frame: Before and 4 months after initiation of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected CTS
Criteria

Inclusion Criteria:

  • wrists with established CTS

Exclusion Criteria:

  • prior surgery for CTS
  • traumatic lesions
  • coexistent neurological disease

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): NCT00694265


Locations
Switzerland
Dep. of Plastic and Hand Surgery, Bern University Hospital
Bern, Switzerland
Sponsors and Collaborators
University of Bern
Investigators
Study Director: Peter Jüni, MD Institute of Social and Preventive Medicine, University of Bern, Switzerland
Principal Investigator: Hans-Rudolf Ziswiler, MD Dep. of Rheumatology, Immunology and Allergology, Bern University Hospital, Switzerland

Publications:
Responsible Party: Peter Jüni, MD, Institute of Social and Preventive Medicine, University of Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00694265     History of Changes
Other Study ID Numbers: CTU_CTS
UBern_CTS
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by University of Bern:
Carpal Tunnel Syndrome
Median Nerve
Ultrasonography
Prospective cohort study

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