NCT00694265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

1.4 years

First QC Date

June 6, 2008

Last Update Submit

August 25, 2008

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromeMedian NerveUltrasonographyProspective cohort study

Outcome Measures

Primary Outcomes (1)

  • Measure of the largest cross-sectional area (CSA) of the median nerve

    Before and 4 months after initiation of treatment

Study Arms (2)

1

Surgical treatment

Procedure: Decompression

2

Conservative treatment

Procedure: Conservative treatment

Interventions

DecompressionPROCEDURE

Surgical decompression of the median nerve

1
Conservative treatmentPROCEDURE

Conservative treatment typically consisted of splinting and corticosteroid injections

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected CTS

You may qualify if:

  • wrists with established CTS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Plastic and Hand Surgery, Bern University Hospital

Bern, Switzerland

Location

Related Publications (2)

  • Ziswiler HR, Reichenbach S, Vogelin E, Bachmann LM, Villiger PM, Juni P. Diagnostic value of sonography in patients with suspected carpal tunnel syndrome: a prospective study. Arthritis Rheum. 2005 Jan;52(1):304-11. doi: 10.1002/art.20723.

    PMID: 15641050BACKGROUND

  • Bachmann LM, Juni P, Reichenbach S, Ziswiler HR, Kessels AG, Vogelin 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. doi: 10.1093/ije/dyi105. Epub 2005 May 23.

    PMID: 15911545BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

DecompressionConservative Treatment

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Peter Jüni, MD

    Institute of Social and Preventive Medicine, University of Bern, Switzerland

    STUDY DIRECTOR

  • Hans-Rudolf Ziswiler, MD

    Dep. of Rheumatology, Immunology and Allergology, Bern University Hospital, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

January 1, 2002

Primary Completion

June 1, 2003

Study Completion

December 1, 2003

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

CH(1)