Contact information
Type
Scientific
Primary contact
Dr Susan Collins
ORCID ID
Contact details
VU Medical Centre
Afdeling Anesthesiologie
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 0293
s.collins@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Complex Regional Pain Syndrome type 1 (CRPS I)
Intervention
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
Drug
Phase
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
01/12/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
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
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
72
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
01/12/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU Medical Centre
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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