Effects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR810
• Date of registration: 21/11/2006
• Primary sponsor: VU University Medical Center, Department of Anesthesiology
• Public title: Effects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients.
• Scientific title: A randomized, double blind study on the effects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients. - N/A
• Date of first enrolment: 1/12/2006
• Target sample size: 72
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=810
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: Susan Collins

• Name: Roberto S.G.M. Perez

Key inclusion & exclusion criteria

Inclusion criteria: 1. Diagnostic criteria for CRPS1 according to the IASP (1):
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 VAS-spontaneous pain score of 5 cm or higher;
3. Patients should be between 18 -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 (2nd) 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Complex regional pain syndrome type 1 (CRPS I)

Intervention(s)

Intravenous Magnesium or placebo.

Primary Outcome(s)

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 3 times daily for a period of one week before each measurement point.

Secondary Outcome(s)

Sensory complaints:
McGill pain questionnaire will be used to obtain information about the type of pain experienced by patients. Semmes Weinstein Monofilaments will be used to objectively measure sensitivity of the skin (e.g. hypesthesia, hyperesthesia and allodynia).
Impairments:
Patients functional status will be assessed with the Impairment Level Sumscore, in which pain (measured by Box scale and McGill pain questionnaire), temperature (measured with infrared thermometer), volume (measured with water displacement volumeter) and active range of motion (measured with goniometers) will be converted into a compound sumscore.
Functional disability: The Radboud Skills Questionnaire, the Walking Stairs Questionnaire and Questionnaire Rising and Sitting Down will be used to assess diasability in patients with respectively upper and lower CRPS1.
Quality of life: The Short Form-36 and EuroQol will be used to measure quality of life.

Secondary ID(s)

ISRCTN66289967

N/A

Source(s) of Monetary Support

SENTER