Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1 - Corticosteroids vs DMSO
- Conditions
- Complex regional pain syndrome type 1. This condition is a pain syndrome with unknown pathophysiology. Research shows that inflammation plays a role in the development and course of the disease. Evidence is low on best treatment, but scavengers such as DMSO, and corticosteroids are described to be benificial.
- Registration Number
- EUCTR2010-019891-54-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 76
Complex regional pain syndrome type 1 (diagnosed using the Budapest criteria)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not being able to give informed consent, another (2nd) chronic pain syndrome, interfering with pain ratings, another syndrome interfering with functional tests, CRPS-1 in both hands or feet, known kidney insufficiency or severe liver disease, active infection, mental retardation, psychiatric abnormality, malignant disease, pregnancy, established severe osteoporosis, established gastric ulcera, hypersensitivity or allergy to prednisolone, use of anti-coagulantia, myasthenia gravis, previous use of DMSO for a period longer than 1 month.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction of inflammatory signs and symptoms of CRPS patients after treatment with DMSO or corticosteroids. ;Secondary Objective: Assessment of safety of treatment with high dosage corticosteroids. <br>Follow up of inflammatory markers in urine and blood plasma after corticosteroid and DMSO treatment. <br>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>Assessment of 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>Health related quality of life as measured by the SF-36. <br>;Primary end point(s): ISS score, a validated compound score consisting of difference in temperature, volume, pain and motor functions between the extremity with CRPS and the contralateral extremity.
- Secondary Outcome Measures
Name Time Method