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Nerve Morphology in Diabetic Patients

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. Identifier: NCT00856011
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : March 5, 2009
Information provided by:
Skane University Hospital

Brief Summary:
The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.

Condition or disease
Peripheral Neuropathy Carpal Tunnel Syndrome Entrapment Neuropathies Diabetes Complications

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Posterior Interosseous Nerve Pathology May Provide Novel Insights Into Both Predisposition and Potential Vascular Basis for the Development of Carpal Tunnel Syndrome in Diabetic Patients.
Study Start Date : December 2003
Actual Study Completion Date : April 2008

Diabetic patients with carpal tunnel syndrome
Non-diabetic patients with carpal tunnel syndrome

Primary Outcome Measures :
  1. Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space

Biospecimen Retention:   Samples Without DNA
Biopsies of the posterior interosseous nerve

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred to a specialized hand clinic

Inclusion Criteria

  • Diagnosis of carpal tunnel syndrome based in clinical history and symptoms
  • Confirmed by nerve conduction studies

Exclusion Criteria

  • Other focal nerve entrapments
  • Cervical radiculopathy
  • Inflammatory joint disease
  • Renal failure
  • Thyroid disorders
  • Previous wrist fracture
  • Long-term exposure to vibrating tools
  • Age under 18

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 identifier (NCT number): NCT00856011

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Dept. of Hand Surgery, Malmo University Hospital
Malmo, Sweden, SE-205 02
Sponsors and Collaborators
Skane University Hospital
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Responsible Party: Niels Thomsen, MD Identifier: NCT00856011    
Other Study ID Numbers: LU 508-03 (2003)
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: March 5, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Diabetes Complications
Neuromuscular Diseases
Nervous System Diseases
Median Neuropathy
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Diabetes Mellitus
Endocrine System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn