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Carpal Tunnel Release in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01201109
Recruitment Status : Unknown
Verified September 2010 by Skane University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : September 14, 2010
Last Update Posted : September 28, 2010
Information provided by:
Skane University Hospital

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
Carpal Tunnel Syndrome Diabetes Nerve Entrapment

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 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 : November 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Diabetic patients operated for carpal tunnel syndrome
Non-diabetic patients operated for carpal tunnel syndrome

Primary Outcome Measures :
  1. 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 :
  1. 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.

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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.

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

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

Dept of Hand Surgery, Skåne University Hospital
Malmö, Sweden, SE 205 02
Sponsors and Collaborators
Skane University Hospital
Study Chair: Lars Dahlin, Md, PhD

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 Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010

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

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