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

August 25, 2008 updated by: University of Bern

Sonographic Follow-up of Patients With Carpal Tunnel Syndrome Undergoing Surgical or Conservative Treatment: Prospective Cohort Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Dep. of Plastic and Hand Surgery, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected CTS

Description

Inclusion Criteria:

  • wrists with established CTS

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTU_CTS
  • UBern_CTS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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