Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1
Phase 3
Completed
- Conditions
- pijn patiënten(post traumatic) dystrophyCRPS
- Registration Number
- NL-OMON34845
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 152
Inclusion Criteria
Patients with CRPS according to the clinical Budapest criteria
Exclusion Criteria
Another (2nd) chronic pain syndrome, interfering with pain ratings; another syndrome interfering with functional tests; CRPS-1 in both hands or feet; known severe kidney insufficiency, severe liver disease; active infection; established severe osteoporosis; gastric ulcera, hypersensitivity or allergy to prednisolone, use of anti-coagulantia, medication, myasthenia gravis, previous use of DMSO for a period longer than 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>As primary outcome the ISS score will be evaluated, which is a compound score<br /><br>consisting of seperate scores based on signs and symptoms that are of<br /><br>importance for patients with CRPS-1. The score goes from 5 till 50 and a<br /><br>clinical relevant result is obtained when the ISS decreases 5 points from<br /><br>baseline or compared to the other treatment group.<br /><br><br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>- Safety of treatment with high dose corticosteroids and tolerance of both<br /><br>therapies is assessed by questionnaires and clinical evaluation.<br /><br>- Reduction of inflammatory markers in urine and blood plasma compared to<br /><br>baseline and between groups.<br /><br>- Reduction of sensory, autonomic and motor disturbances as measured by the<br /><br>McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and<br /><br>temperature assessments compared to baseline and the DMSO group compared to the<br /><br>corticosteroid group.<br /><br>- Increase of functional status of the affected extremity as measured by the<br /><br>Walking Ability Questionnaire for lower extremity CRPS-1, and Radboud Skills<br /><br>Questionnaire for upper extremity CRPS-1 compared to the baseline and between<br /><br>the groups.<br /><br>- Improvement of health related quality of life as measured by the SF-36 to the<br /><br>baseline and between the groups.</p><br>