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Nerve Morphology in Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856011
First Posted: March 5, 2009
Last Update Posted: March 5, 2009
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 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
Peripheral Neuropathy Carpal Tunnel Syndrome Entrapment Neuropathies Diabetes Complications

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • 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

Enrollment: 46
Study Start Date: December 2003
Study Completion Date: April 2008
Groups/Cohorts
1
Diabetic patients with carpal tunnel syndrome
2
Non-diabetic patients with carpal tunnel syndrome

  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:   Probability Sample
Study Population
Patients referred to a specialized hand clinic
Criteria

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
  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): NCT00856011


Locations
Sweden
Dept. of Hand Surgery, Malmo University Hospital
Malmo, Sweden, SE-205 02
Sponsors and Collaborators
Skane University Hospital
  More Information

Responsible Party: Niels Thomsen, MD
ClinicalTrials.gov Identifier: NCT00856011     History of Changes
Other Study ID Numbers: LU 508-03 (2003)
First Submitted: March 4, 2009
First Posted: March 5, 2009
Last Update Posted: March 5, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Syndrome
Peripheral Nervous System Diseases
Carpal Tunnel Syndrome
Diabetes Complications
Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Disease
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Median Neuropathy
Mononeuropathies
Sprains and Strains
Wounds and Injuries
Diabetes Mellitus
Endocrine System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn