Primary aim of the study is to evaluate the efficacy and safety of intramuscular magnesiumsulphate in CRPS I patients during 3 weeks dose escalation study.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is severity of dystonia using the Burke-Fahn-Marsden scale
Secondary outcome
1. Severity of pain and dystonia using a NRS.
2. Severity of pain using the McGill Pain Questionnaire.
3. Assessment of the severity of dystonia using a device measuring the passive
joint range of motion, and muscle resistance to passive movement.
4. Patient Preference Questionnaire.
5. The global impression scale.
6. Safety of the procedure as evaluated by the occurence of adverse events.
Background summary
Many patients with dystonia in CRPS I show insufficient or no benefit on oral
medication, physiotherapy, splints or other treatments. Administration of
intrathecal baclofen is an invasive treatment since a pumpimplantation is
required combined with the risk of technical complications to the pumpsysteem.
The administration of magnesiumsulphate proved to have a muscle relaxant effect
in many areas and intramuscular administration is possible, which supports
adequate systemic distribution and treatment over a longer period of time on a
daily basis. Furthermore patiënts are able to autoinject the studymedication in
their own environment.
Study objective
Primary aim of the study is to evaluate the efficacy and safety of
intramuscular magnesiumsulphate in CRPS I patients during 3 weeks dose
escalation study.
Study design
Forty patients suffering from CRPS type 1 and dystonia will receive
intramuscular magnesiumsulphate (3 weeks) and placebo (3 weeks) in a
dubbelblind crossover manner. Every week for a period of 3 weeks the dose of
study medication will be raised following a predefined dose escalation scheme.
After the first 3 weeks no study medication will be administered for one week
to create a washout period. The next 3 weeks study medication is resumed
following the dose escalation scheme identical to the first period.
Intervention
Intramuscular treatment with magnesiumsulphate or placebo (NaCl 0,9%).
Administration will start with a dose of 500 mg, two times a day, and raised to
a maximum of 750 mg, three times a day or 1000 mg, twice a day.
Study burden and risks
1. risk of pain at the site of injection
2. a slight risk of exacerbation of symptoms of CRPS as the injection resembles
a minor traumatic event
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
1. Patients must fulfill the diagnostic criteria of the IASP 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 criteria
1. 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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010087-42-NL |
| CCMO | NL26827.058.09 |