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

Completed

• Conditions: dystonia of enlarged muscle tone; 10028037

• Registration Number: NL-OMON33281
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified