Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1

Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1 - Corticosteroids vs DMSO on CRPS-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34845

Enrollment

152

Registered

2010-08-03

Start date

2010-11-30

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pijn patiënten (post traumatic) dystrophy CRPS

Interventions

Patients will be treated with DMSO cream 5 times a day, combined with placebo oral medication during a period of 26 days (tapering period included) or with prednisolone 60 mg/day during 2 weeks, whe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with CRPS according to the clinical Budapest criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
As primary outcome the ISS score will be evaluated, which is a compound score consisting of seperate scores based on signs and symptoms that are of importance for patients with CRPS-1. The score goes from 5 till 50 and a clinical relevant result is obtained when the ISS decreases 5 points from baseline or compared to the other treatment group.	—

Secondary

Measure	Time frame
- Safety of treatment with high dose corticosteroids and tolerance of both therapies is assessed by questionnaires and clinical evaluation. - Reduction of inflammatory markers in urine and blood plasma compared to baseline and between groups. - Reduction of sensory, autonomic and motor disturbances as measured by the McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and temperature assessments compared to baseline and the DMSO group compared to the corticosteroid group. - Increase of 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 compared to the baseline and between the groups. - Improvement of health related quality of life as measured by the SF-36 to the baseline and between the groups.	—

Measure

Time frame

- Safety of treatment with high dose corticosteroids and tolerance of both therapies is assessed by questionnaires and clinical evaluation. - Reduction of inflammatory markers in urine and blood plasma compared to baseline and between groups. - Reduction of sensory, autonomic and motor disturbances as measured by the McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and temperature assessments compared to baseline and the DMSO group compared to the corticosteroid group. - Increase of 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 compared to the baseline and between the groups. - Improvement of health related quality of life as measured by the SF-36 to the baseline and between the groups.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)