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Carpal Tunnel Release in Diabetic Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Skane University Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201109
First Posted: September 14, 2010
Last Update Posted: September 28, 2010
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.
Information provided by:
Skane University Hospital
  Purpose
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
Carpal Tunnel Syndrome Diabetes Nerve Entrapment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Patient self-reported outcome questionnaire [ Time Frame: 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:
  • Nerve conduction study and vibrotactile sense [ Time Frame: 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.



Enrollment: 66
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetics
Diabetic patients operated for carpal tunnel syndrome
Non-diabetics
Non-diabetic patients operated for carpal tunnel syndrome

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201109


Locations
Sweden
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
  More Information

Responsible Party: Niels Thomsen, MD, PhD, Dept of Hand Surgery, Skåne University Hospital, Malmö
ClinicalTrials.gov Identifier: NCT01201109     History of Changes
Other Study ID Numbers: 2010/354
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: September 28, 2010
Last Verified: September 2010

Keywords provided by Skane University Hospital:
Carpal tunnel syndrome
Entrapment neuropathies
Diabetes

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