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

This study has been completed.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00694265
First received: June 6, 2008
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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 Intervention
Carpal Tunnel Syndrome
Procedure: Decompression
Procedure: Conservative treatment

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Measure of the largest cross-sectional area (CSA) of the median nerve [ Time Frame: Before and 4 months after initiation of treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: January 2002
Study Completion Date: December 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: June 6, 2008
Last Updated: August 25, 2008
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Cumulative Trauma Disorders
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014