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Evoked Fields After Median and Ulnar Stimulation

M

Medical Center Alkmaar

Status

Completed

Conditions

Complex Regional Pain Syndromes

Treatments

Other: Evoked fields before and after a local block (Xylocaine)

Study type

Observational

Funder types

Other

Identifiers

NCT00217243
NH04-196

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

17 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

60 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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