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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00694265
Other study ID # CTU_CTS
Secondary ID UBern_CTS
Status Completed
Phase N/A
First received June 6, 2008
Last updated August 25, 2008
Start date January 2002
Est. completion date December 2003

Study information

Verified date August 2008
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- wrists with established CTS

Exclusion Criteria:

- prior surgery for CTS

- traumatic lesions

- coexistent neurological disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Decompression
Surgical decompression of the median nerve
Conservative treatment
Conservative treatment typically consisted of splinting and corticosteroid injections

Locations

Country Name City State
Switzerland Dep. of Plastic and Hand Surgery, Bern University Hospital Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Bachmann LM, Jüni P, Reichenbach S, Ziswiler HR, Kessels AG, Vögelin E. Consequences of different diagnostic "gold standards" in test accuracy research: Carpal Tunnel Syndrome as an example. Int J Epidemiol. 2005 Aug;34(4):953-5. Epub 2005 May 23. — View Citation

Ziswiler HR, Reichenbach S, Vögelin E, Bachmann LM, Villiger PM, Jüni P. Diagnostic value of sonography in patients with suspected carpal tunnel syndrome: a prospective study. Arthritis Rheum. 2005 Jan;52(1):304-11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of the largest cross-sectional area (CSA) of the median nerve Before and 4 months after initiation of treatment No
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