Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Susan Collins


Contact details

VU Medical Centre
Afdeling Anesthesiologie
1081 HV
+31 (0)20 444 0293

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Magnesium sulphate reduces pain for more than 50% on the Box scale when compared to the baseline, and for more than two points to the placebo group.

Ethics approval

Approval received from the Medical Ethical Review Committee of the VU University Medical Center on the 26th February 2007 (ref: 2004/153).

Study design

Randomised, double blinded, placebo controlled, parallel group trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Complex Regional Pain Syndrome type 1 (CRPS I)


Intervention: 70 mg/kg magnesium sulphate continuously administered in four hours via an intravenous infusion (in two 50 ml syringe) of 24 ml/hour a day for a period of five days
Control: an equal amount of NaCl 0.9% solution (in two 50 ml syringe) continuously in four hours via an intravenous infusion of 24 ml/hour a day for a period of five days

Intervention type



Not Specified

Drug names

Magnesium sulphate

Primary outcome measures

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.

Secondary outcome measures

1. Sensory complaints:
a. McGill pain questionnaire will be used to obtain information about the type of pain experienced by patients
b. Semmes Weinstein Monofilaments will be used to objectively measure sensitivity of the skin (e.g. hypesthesia, hyperesthesia and allodynia)
2. 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
3. Functional disability: the Radboud Skills Questionnaire, the Walking Stairs Questionnaire and Questionnaire Rising and Sitting Down will be used to assess disability in patients with respectively upper and lower CRPS1
4. Quality of life: The 36-item Short Form (SF-36) and European Quality of Life (EuroQol) questionnaires will be used to measure quality of life

Secondary outcomes will be measured at baseline, 1, 3, 6 and 12 weeks after treatment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group

Not Specified


Not Specified

Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

VU Medical Centre
1081 HV

Sponsor information


Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Anesthesiology
P.O. Box 7057
1007 MB

Sponsor type

Hospital/treatment centre



Funder type


Funder name

SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes