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Double-blind randomised placebo-controlled cross-over study to investigate the effectiveness of intramuscular magnesium on pain and dystonia in Complex Regional Pain Syndrome type 1.


- candidate number6004
- NTR NumberNTR1873
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2009
- Secondary IDsP09.021 (METC AMC) NL26827.058.09 ( Centrale Commissie Mensgebonden Onderzoek)
- Public TitleDouble-blind randomised placebo-controlled cross-over study to investigate the effectiveness of intramuscular magnesium on pain and dystonia in Complex Regional Pain Syndrome type 1.
- Scientific TitleDouble-blind randomised placebo-controlled cross-over study to investigate the effectiveness of intramuscular magnesium on pain and dystonia in Complex Regional Pain Syndrome type 1.
- ACRONYMthe IMCORE study
- hypothesisAdministration of magnesiumsulphate has the potential to elicit muscle relaxation. We hypothesize administration of intramuscular magnesiumsulphate can reduce CRPS-related dystonia.
- Healt Condition(s) or Problem(s) studiedComplex regional pain syndrome type 1 (CRPS I), Dystonia
- Inclusion criteria1. Patients must fulfill the diagnostic criteria of the consensus report of CRPS I:
A. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event, and;
B. Evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain, and;
C. No condition that would otherwise account for the degree of pain and dysfunction.
2. Patients must suffer from clinically significant tonic or intermittent dystonia in one or more extremities;
3. Patients must have symptoms for at least 1 year.
- Exclusion criteria1. Patients are excluded if they can obtain satisfactory relief of symptoms with conventional treatments;
2. Patients with a history of alcohol or drugs abuse within the past year;
3. Patients with clinically significant psychiatric illness;
4. Pregnant, nursing women and females of childbearing potential not using effective contraception;
5. Patients who are unlikely to comply with study requirements or have a history of poor compliance to medical regimens or study requirements;
6. Patients with an insufficient command and understanding of the Dutch language;
7. Patients involved in legal proceedings (claiming compensation for their CRPS I);
8. Patients with impaired coagulation;
9. Patients with impaired renal function (i.e. serum creatinine below 10 or exceeding 80 µmol/l);
10. Patients with hypermagnesaemia (i.e. total serum Mg exceeding 1.10 mmol/l);
11. Patients requiring the use of diuretics.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-okt-2010
- Target number of participants40
- InterventionsIntramuscular magnesiumsulphate:
1. Week 1: 500 mg twice a day;
2. Week 2: 750 mg twice a day;
3. Week 3: 1000 mg twice a day.
- Primary outcomePrimary outcome is severity of dystonia using the Burke-Fahn-Marsden scale.
- Secondary outcomeSecondary outcomes are:
1. Efficacy as evaluated by pain and dystonia severity using NRS, McGill Pain Questionnaire, a device measuring the passive joint range of motion and muscle resistance to passive movement, patient’s preference questionnaire (PPQ), and global impression of improvement after each treatment (global impression scale);
2. Safety of the procedure as evaluated by the occurrence of adverse events.
- TimepointsOne week before first injection until 7 weeks after first injection:
1. Self-assessment every day;
2. Other assessments once every week.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD A.A. Plas, v.d
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Hilten, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
TREND Delft
- PublicationsN/A
- Brief summaryA large proportion of chronic patients with complex regional pain syndrome type 1 (CRPS I) suffer from both neuropathic pain and dystonia. Findings from neurophysiological and intrathecal baclofen (ITB) studies highlight an impaired inhibitory neurotransmission. Since magnesium plays an important inhibitory role in motor regulation, magnesium administration may offer new options for the treatment of movement disorders in patients with CRPS I. Primary aim of the study is to evaluate the efficacy and safety of intramuscular magnesium (IMMG) in CRPS I in a double-blind randomised placebo-controlled cross-over manner.
- Main changes (audit trail)
- RECORD22-jun-2009 - 6-okt-2009


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