No registrations found.
ID
Source
Brief title
Health condition
complex regional pain syndrome type-1
Sponsors and support
investigator initiated research
Intervention
Outcome measures
Primary outcome
Primary Objective:
Assessment of a group difference in clinically important improvement in functional outcome of at least 10 points as measured by the DASH questionnaire
Secondary outcome
Secondary Objective(s):
1. To determine if there is a group difference in improvement in global perceive effect of therapy as measured on a 7 point scale
2. To determine if there is a group difference in improvement in pain intensity scores as measured by a pain diary three times daily during the week before each study visit.
3. To determine if there is a group difference in improvement in edema as measured by a measurement tape
4. To determine if there is a group difference in improvement in discoloration as measured on a 3 point scale
5. To determine if there is a group difference in cortisol levels of responders to treatment versus non responders. A responder is a subject who has at least 10 points improvement in the DASH questionnaire
Study objective
the active treatment group has an improvement of at least 10 points of DASH functional outcome more than the placebo group.
Study design
Follow up will be at 1, 3, 6, 9 and 12 months after randomization and start of treatment
Intervention
prednisolon versus placebo
Yzabel Vandevivere
Postbus 90151
Tilburg 5000 LC
The Netherlands
y.vandevivere@elisabeth.nl
Yzabel Vandevivere
Postbus 90151
Tilburg 5000 LC
The Netherlands
y.vandevivere@elisabeth.nl
Inclusion criteria
1. CRPS-1 (clinical Budapest criteria) in one arm only.
2. Inflammatory type: painful upper extremity, temperature difference, swelling, red
discoloration, limited hand function.
3. Occurring after trauma or upper extremity surgery
4. Acute stadium of less than 12 months duration
5. Diminished functioning of the upper extremity as established by a DASH score of 10 or more (Hudak, 1996)
6. Average pain score of 3 or more on a one week pain diary, three times daily
7. No indication for surgical therapy or no future surgery planned
8. Age 18-80
Exclusion criteria
1. Not able to comply with follow up visits
2. < 18 or > 80 years of age
3. More than one extremity involved
4. Body temperature of ¡Ý 38 degrees Celsius
5. Elevated white blood cell count (> 10-E9 / liter)
6. Elevated BSE or CRP
7. Associated Infectious disease
8. Peptic ulcer
9. Pregnancy
10. Coagulation disorders, use of anticoagulants
11. Untreated hypertension
12. Untreated diabetes
13. Untreated cardiac failure
14. Current steroid use
15. Liver or kidney failure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5261 |
| NTR-old | NTR5377 |
| CCMO | NL-OSTIN 2015-003 |