Nerve Entrapment in Diabetic Patients

October 17, 2008 updated by: Skane University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmo, Sweden, 205 02
        • Dept. of Hand Surgery, Malmo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to a specialized hand clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
1
Patients with diabetes and carpal tunnel syndrome

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pillar pain, cold intolerance, and patient satisfaction.
Time Frame: Baseline, 6 weeks, 12 weeks, 52 weeks
Baseline, 6 weeks, 12 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Investigators

  • Principal Investigator: Lars Dahlin, PHD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU 508-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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