Carpal Tunnel Release in Diabetic Patients

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01201109
• Other study ID #: 2010/354
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 13, 2010
• Last updated: September 27, 2010
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Diabetes
• Nerve Entrapment

Locations

Country	Name	City	State
Sweden	Dept of Hand Surgery, Skåne University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-reported outcome questionnaire	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	No
Secondary	Nerve conduction study and vibrotactile sense	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	No