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van CCT (UK)

van CCT (UK)

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

- candidate number2322
- NTR NumberNTR810
- Date ISRCTN created2-mei-2007
- date ISRCTN requested20-apr-2007
- Date Registered NTR21-nov-2006
- Secondary IDsN/A 
- Public TitleEffects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients.
- Scientific TitleA randomized, double blind study on the effects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients.
- hypothesisMagnesium Sulphate reduces pain for more than 50% on the Box scale when compared to the baseline, and for more than 2 points to the placebo group.
- Healt Condition(s) or Problem(s) studiedComplex regional pain syndrome type 1 (CRPS I)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2006
- planned closingdate1-jul-2008
- Target number of participants72
- InterventionsIntravenous Magnesium or placebo.
- Primary outcomePain 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 outcomeSensory 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.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center, Department of Anesthesiology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThere is increasing evidence suggesting that the inflammatory response in Complex Regional Pain Syndrome type 1 (CRPS1) may result from a perturbed function of C and Adelta-fibres releasing neuropeptides in response to tissue damage. This process may initiate chemical and physiological changes at the spinal chord level that are associated with increased excitability of neurons, such that spontaneous pain, allodynia and/or hyperalgesia occur. This process of central sensitisation is considered a leading factor in the development of chronic pain. To counter this neurogenic wind-up phenomenon, and counter the vicious circle of sensitisation and further release of neuropeptides, NMDA antagonists are being used. Evidence in acute as well as chronic pain treatment suggests that Magnesium prevents the activation of the NMDA mechanism responsible for the generation of neuropathic pain. This randomised, double blind placebo-controlled study will be performed to evaluate the involvement of NMDA receptor activation in the pathophysiology of CRPS1. Furthermore, the effect of Magnesium on pain, functional status, and quality of life in CRPS1 patients will be compared between Magnesium and Sodium chloride (NaCl) infusion.
- Main changes (audit trail)
- RECORD21-nov-2006 - 7-mei-2007

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