Carpal Tunnel Release in Diabetic Patients

• Conditions: Diabetes; Nerve Entrapment; Carpal Tunnel Syndrome

• Registration Number: NCT01201109
• Lead Sponsor: Skane University Hospital

Brief 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.

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 Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28
• Study Start: 2010-11
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient self-reported outcome questionnaire	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

Secondary Outcome Measures

Name	Time	Method
Nerve conduction study and vibrotactile sense	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.

Trial Locations

Locations (1)

Dept of Hand Surgery, Skåne University Hospital; 🇸🇪 Malmö, Sweden