Value of surgical decompression of the nerves of the lower extremities in patients with painful diabetic polyneuropathy: Lower Extremity Nerve entrapment Study (LENS)
Completed
- Conditions
- 1003460610012653nerve entrapment caused by diabetes10009720
- Registration Number
- NL-OMON39394
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
Painful Diabetic Neuropathy
positive Tinel sign
age 18-90;first control group: the same inclusion criteria but without diabetic neuropathy
second control group: people without diabetes mellitus and without neuropathy
Exclusion Criteria
need for vascular surgical intervention of the extremity
ulcers on the foot
Sufficiënt treatment of pain with medication( VAS 0-1)
neuropathy caused by other factors than diabetes mellitus
patients with physical problems leading to instability;control group: anamnestic signs of periheral neuropathy
control group ultrasound: anamnastic signs of peripheral neuropathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To study the influence of decompression on pain.<br /><br><br /><br>Evaluation of pain with the Visual Analogue Scale.<br /><br>The VAS will be used for both legs separately.<br /><br>The VAS is a straight line, the ends of which are the extreme limits of the<br /><br>sensation being assessed. The line is 10 cm in length using a 10-point scale<br /><br>ranging from 1 to 10, with 1 being barely perceptible and 10 being intolerably<br /><br>painful. Primary endpoint will be VAS<2 or a significant greater change in VAS<br /><br>in the surgery group compared with the control group after 6 months. </p><br>
- Secondary Outcome Measures
Name Time Method