Prednisolone or DMSO for the treatment of CRPS-1 (post-traumatic dystrophy).

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27005

Enrollment

Registered

2011-01-25

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Complex Regional Pain Syndrome type 1 Complex Regionaal Pijn Syndroom type 1, post-traumatische dystrofie

Interventions

Group A: Prednisolone 60 mg/day during 2 weeks, where after tapered every 4 days with 20 mg, combined with placebo cream 5 times a day. Group B: DMSO cream 50% 5 times a day, combined with placebo

Eligibility

Inclusion criteria

Inclusion criteria: CRPS-1 according to the Budapest criteria for clinical diagnosis.

Exclusion criteria

Exclusion criteria: 1. Age < 18; 2. Not being able to give informed consent; 3. Another (2nd) chronic pain syndrome, interfering with pain ratings; 4. Another syndrome interfering with functional tests; 5. CRPS-1 in both hands or feet; 6. Known kidney insufficiency or severe liver disease; 7. Active infection; 8. Mental retardation; 9. Psychiatric abnormality; 10. Malignant disease; 11. Pregnancy; 12. Established severe osteoporosis; 13. Established gastric ulcera; 14. Hypersensitivity or allergy to prednisolone or DMSO; 15. Use of anti-coagulantia; 16. Myasthenia gravis; 17. Previous use of DMSO for a period longer than 1 month.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Safety of treatment with high dosage prednisolone is assessed by questionnaires and clinical evaluation; 2. Inflammatory markers in urine and blood plasma after prednisolone and DMSO treatment; 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; 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; 5. Health related quality of life as measured by the SF-36.	—

Measure

Time frame

1. Safety of treatment with high dosage prednisolone is assessed by questionnaires and clinical evaluation; 2. Inflammatory markers in urine and blood plasma after prednisolone and DMSO treatment; 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; 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; 5. Health related quality of life as measured by the SF-36.

—

Contacts

Public ContactS.G.L. Fischer

VUmc, afdeling 6F kamer 002, anesthesiologie Postbus 7057

s.fischer@vumc.nl+31 (0)20-4440293

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)