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.
Recruiting
- Conditions
- Dystonia in complex regional pain syndrome type 1.
- Registration Number
- NL-OMON22797
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. 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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is severity of dystonia using the Burke-Fahn-Marsden scale.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are:<br /><br>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);<br /> <br>2. Safety of the procedure as evaluated by the occurrence of adverse events.<br>