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Carpal Tunnel Release in Diabetic Patients

Sponsor
Skane University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01201109
Collaborator
(none)
66
Enrollment
1
Location
13
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Follow-up investigation includes:

    1. Clinical examination of sensory and motor function

    2. Generic and disease specific self-administered questionnaires

    3. Nerve conduction study

    4. Vibration threshold testing

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    66 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients
    Study Start Date :
    Nov 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2011
    Anticipated Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Diabetics

    Diabetic patients operated for carpal tunnel syndrome
    Non-diabetics

    Non-diabetic patients operated for carpal tunnel syndrome

    Outcome Measures

    Primary Outcome Measures

    1. Patient self-reported outcome questionnaire [5 years after carpal tunnel release]

      Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score

    Secondary Outcome Measures

    1. Nerve conduction study and vibrotactile sense [5 years after carpal tunnels release]

      Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment. Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity. Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.
    Exclusion Criteria:

    • previous carpal tunnel release in the hand under study

    • clinical signs of nerve entrapment other than CTS

    • cervical radiculopathy, inflammatory joint disease

    • renal failure

    • thyroid disorders

    • previous wrist fracture on the affected side

    • daily long-term exposure to vibrating tools

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Hand Surgery, Skåne University Hospital Malmö Sweden SE 205 02

    Sponsors and Collaborators

    • Skane University Hospital

    Investigators

    • Study Chair: Lars Dahlin, Md, PhD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01201109
    Other Study ID Numbers:
    • 2010/354
    First Posted:
    Sep 14, 2010
    Last Update Posted:
    Sep 28, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Carpal tunnel syndrome
    Entrapment neuropathies
    Diabetes
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Nerve Compression Syndromes

    Study Results

    No Results Posted as of Sep 28, 2010