Effects of continuous intravenous magnesium on features of central sensitisation in complex regional pain syndrome type one patients

Not Applicable

Completed

• Conditions: Complex Regional Pain Syndrome type 1 (CRPS I); Signs and Symptoms; Pain syndrome

• Registration Number: ISRCTN66289967
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23889940 (added 09/05/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Study Completion: 2008-07-01
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

1. Diagnostic criteria for Complex Regional Pain Syndrome type one (CRPS1) according to the International Association for the Study of Pain (IASP):
a. presence of an initiating noxious event or cause for immobilisation
b. continuing pain, allodynia or hyperalgesia, with which the pain is disproportioned to any inciting event and is not limited to the area of an individual peripheral nerve
c. evidence at any time of oedema. Skin blood flow abnormality, or abnormal sudomotor activity in the painful area since the inciting event
d. conditions which could otherwise account for the level of pain and dysfunction should be excluded
Note: criteria b-d have to be met
2. A Visual Analogue Scale (VAS)-spontaneous pain score of 5 cm or higher
3. Patients should be between 18 to 70 years old
4. CRPS1 in one extremity
5. First time experience of patient with CRPS1
6. Other medication has to be stopped for more then one week before the trial starts
7. Patients should give written informed consent

Exclusion Criteria

1. Not being able to give informed consent
2. Another (second) chronic pain syndrome, interfering with pain ratings
3. Another syndrome interfering with functional tests
4. CRPS1 in both hands or feet
5. Patient has experienced CRPS1 before
6. Known kidney and/or severe liver disease
7. Known nerve damage in the affected area
8. Active infection
9. Mental retardation
10. Psychiatric abnormality
11. Malignant disease
12. Patients with heart failure
13. Patients with pacemakers or implanted defibrillators
14. Patients with pulmonary congestion
15. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain will be measured in a pain diary at baseline, 1, 3, 6 and 12 weeks after treatment. In this diary patients will record their pain rate on a 11 point Box scale three times daily for a period of one week before each measurement point.