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Nerve Entrapment in Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775333
First Posted: October 20, 2008
Last Update Posted: October 20, 2008
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 in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

Condition Intervention
Carpal Tunnel Syndrome Entrapment Neuropathies Nerve Compression Syndromes Diabetes Complications Procedure: Outcome after carpal tunnel release

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength) [ Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks ]

Secondary Outcome Measures:
  • Pillar pain, cold intolerance, and patient satisfaction. [ Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks ]

Enrollment: 67
Study Start Date: December 2003
Study Completion Date: April 2008
Groups/Cohorts Assigned Interventions
1
Patients with diabetes and carpal tunnel syndrome
2
Non-diabetic patients with carpal tunnel syndrome
Procedure: Outcome after carpal tunnel release
Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients

  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
Patients referred to a specialized hand clinic
Criteria

Inclusion Criteria:

  • Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
  • 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.
  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): NCT00775333


Locations
Sweden
Dept. of Hand Surgery, Malmo University Hospital
Malmo, Sweden, 205 02
Sponsors and Collaborators
Skane University Hospital
Investigators
Principal Investigator: Lars Dahlin, PHD
  More Information

Responsible Party: Niels Thomsen, MD, Dept. of Hand Surgery, Malmo University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00775333     History of Changes
Other Study ID Numbers: LU 508-03
First Submitted: October 17, 2008
First Posted: October 20, 2008
Last Update Posted: October 20, 2008
Last Verified: October 2008

Keywords provided by Skane University Hospital:
Carpal Tunnel Syndrome
Diabetes
APB strength
Sensory Function
Pillar Pain
Cold Intolerance
Patient Satisfaction

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