Nerve Entrapment in Diabetic Patients

Verified by: Skane University Hospital, October 2008
First Received: October 17, 2008 | Last Updated: October 17, 2008 | Phase: N/A | Start Date: December 2003
Overall Status: Completed | Estimated Enrollment: 67
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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...

Brief Summary

Official Title: “Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Case Control, Time Perspective: Prospective

Intervention(s) in this Clinical Trial

  • Procedure: Outcome after carpal tunnel release
    • Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients

Arms, Groups and Cohorts in this Clinical Trial

  • : 1
    • Patients with diabetes and carpal tunnel syndrome
  • : 2
    • Non-diabetic patients with carpal tunnel syndrome

Outcome Measures for this Clinical Trial

Primary Measures

  • Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)
    • Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks
      Safety Issue?: No

Secondary Measures

  • Pillar pain, cold intolerance, and patient satisfaction.
    • Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Skane University Hospital Other

Overall Clinical Trial Officials and Contacts

Lars Dahlin, PHD Principal Investigator   

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00775333

Study ID Number: LU 508-03

ClinicalTrials.gov Identifier: NCT00775333

Health Authority: Sweden: Regional Ethical Review Board

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00775333