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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 6, 2008
First Posted Date June 10, 2008
Last Update Posted Date August 26, 2008
Study Start Date January 2002
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2008)
Measure of the largest cross-sectional area (CSA) of the median nerve [ Time Frame: Before and 4 months after initiation of treatment ]
Original Primary Outcome Measures
 (submitted: June 9, 2008)
Measure of the largest cross-sectional area (CSA) of the median nerve [ Time Frame: Befor and 4 months after initiation of treatment ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment
Official Title Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment: Prospective Cohort Study.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with suspected CTS
Condition Carpal Tunnel Syndrome
Intervention
  • Procedure: Decompression
    Surgical decompression of the median nerve
  • Procedure: Conservative treatment
    Conservative treatment typically consisted of splinting and corticosteroid injections
Study Groups/Cohorts
  • 1
    Surgical treatment
    Intervention: Procedure: Decompression
  • 2
    Conservative treatment
    Intervention: Procedure: Conservative treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2008)
55
Original Actual Enrollment Same as current
Actual Study Completion Date December 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • wrists with established CTS

Exclusion Criteria:

  • prior surgery for CTS
  • traumatic lesions
  • coexistent neurological disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00694265
Other Study ID Numbers CTU_CTS
UBern_CTS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Jüni, MD, Institute of Social and Preventive Medicine, University of Bern, Switzerland
Study Sponsor University of Bern
Collaborators Not Provided
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
PRS Account University of Bern
Verification Date August 2008