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Nerve Entrapment in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00775333
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pillar pain, cold intolerance, and patient satisfaction. [ Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 17, 2008
Last Updated: October 17, 2008
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013