Carpal Tunnel Release in Diabetic Patients

September 27, 2010 updated by: Skane University Hospital

Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients

The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

Study Overview

Status

Unknown

Conditions

Detailed Description

The Follow-up investigation includes:

  1. Clinical examination of sensory and motor function
  2. Generic and disease specific self-administered questionnaires
  3. Nerve conduction study
  4. Vibration threshold testing

Study Type

Observational

Enrollment (Actual)

66

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
      • Malmö, Sweden, SE 205 02
        • Dept of Hand Surgery, Skåne 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

Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.

Description

Inclusion Criteria:

  • diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.

Exclusion Criteria:

  • previous carpal tunnel release in the hand under study
  • clinical signs of nerve entrapment other than CTS
  • cervical radiculopathy, inflammatory joint disease
  • renal failure
  • thyroid disorders
  • previous wrist fracture on the affected side
  • daily long-term exposure to vibrating tools
  • pregnancy

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Diabetics
Diabetic patients operated for carpal tunnel syndrome
Non-diabetics
Non-diabetic patients operated for carpal tunnel syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported outcome questionnaire
Time Frame: 5 years after carpal tunnel release
Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score
5 years after carpal tunnel release

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve conduction study and vibrotactile sense
Time Frame: 5 years after carpal tunnels release

Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment.

Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity.

Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz.
5 years after carpal tunnels release

Collaborators and Investigators

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

Sponsor

Skane University Hospital

Investigators

  • Study Chair: Lars Dahlin, Md, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 27, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/354

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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