Evoked Fields After Median and Ulnar Stimulation

Completed

• Conditions: Complex Regional Pain Syndromes
• Interventions: Other: Evoked fields before and after a local block (Xylocaine)

• Registration Number: NCT00217243
• Lead Sponsor: Medical Center Alkmaar

Brief Summary

In order to be able to study the effects of evoked fields with magnetoencephalography (MEG) in two groups of patients, comparison is made with a group of healthy volunteers.

Detailed Description

This study is directed at the (central and / or peripheral) mechanisms of pain and the cortical changes (plasticity) due to chronic non-malignant pain in two groups of patients and one healthy volunteer group.

The aim of the study is further to evaluate cortical processes by MEG (and fMRI, if feasible) to quantify and qualify the responses, localise the generators and study the effects of a pain therapy.

To search for patterns that may result in diagnostic criteria and have an indicative value for the treatment and the monitoring of the effects.

Finally the study not only intends to support clinical diagnosis but also to provide tools to monitor treatment and support the choice (algorithm) between SCS and SAN. An algorithm, facilitating decision making between these two treatments, will be promoted. It should also provide a clinical decision tool for the use of SAN

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Study Completion: 2007-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

CRPS I:

• (Absolute) functio laesa, secondary pain and cold sensations
• (Relative) abnormal skin colour, allodynia, hyperalgesia, hyperpathia, hyperhydrosis,oedema, increased nail growth, increased hair growth. (At least 4 need to be present).

CRPS II:

• All the previous but evidence of traumatic peripheral nerve injury.

Exclusion Criteria

• General condition
• Pregnancy
• Technical implants (pacemaker, SCS: disturbs MEG)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pain study Netherlands	Evoked fields before and after a local block (Xylocaine)	20 healthy subjects 20 patients with a traumatic unilateral peripheral nerve injury 20 patients with CRPS I

Trial Locations

Locations (1)

Medical Center of Alkmaar; 🇳🇱 Alkmaar, NH, Netherlands