Prednisolone or DMSO for the treatment of CRPS-1 (post-traumatic dystrophy).
Recruiting
- Conditions
- Complex Regional Pain Syndrome type 1Complex Regionaal Pijn Syndroom type 1, post-traumatische dystrofie
- Registration Number
- NL-OMON27005
- Lead Sponsor
- Ministery of Economics, (BSIK03016)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 76
Inclusion Criteria
CRPS-1 according to the Budapest criteria for clinical diagnosis.
Exclusion Criteria
1. Age < 18;
2. Not being able to give informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of inflammatory signs and symptoms measured by the Impairment Level Sum Score (ISS). The ISS is a validated measurement index consisting of pain, temperature, volume and range of motion differences between the affected and the contra-lateral extremity, whereby a difference score of 5 points or more between the treatment groups or compared to baseline is considered clinically relevant.
- Secondary Outcome Measures
Name Time Method 1. Safety of treatment with high dosage prednisolone is assessed by questionnaires and clinical evaluation;<br /><br>2. Inflammatory markers in urine and blood plasma after prednisolone and DMSO treatment;<br /><br>3. Course of sensory, autonomic and motor disturbances as measured by the McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and temperature assessments significantly in both groups;<br /><br>4. The functional status of the affected extremity as measured by the Walking Ability Questionnaire for lower extremity CRPS-1, and Radboud Skills Questionnaire for upper extremity CRPS-1;<br /><br>5. Health related quality of life as measured by the SF-36.