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

ISRCTN	ISRCTN66289967
DOI	https://doi.org/10.1186/ISRCTN66289967
Protocol serial number	N/A
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)

Submission date: 02/05/2007
Registration date: 02/05/2007
Last edited: 09/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Susan Collins
Scientific

VU Medical Centre
Afdeling Anesthesiologie
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 0293
Email	s.collins@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of continuous intravenous magnesium on features of central sensitisation in complex regional pain syndrome type one patients
Study objectives	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(s)	Approval received from the Medical Ethical Review Committee of the VU University Medical Center on the 26th February 2007 (ref: 2004/153).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Magnesium sulphate
Primary outcome measure(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 three times daily for a period of one week before each measurement point.
Key secondary outcome measure(s)	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.
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	72
Total final enrolment	56
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

VU Medical Centre

Amsterdam
1081 HV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013	09/05/2019	Yes	No

Editorial Notes

09/05/2019: Publication reference and total final enrolment added.