the active treatment group has an improvement of at least 10 points of DASH functional outcome more than the placebo group.
ID
Bron
Verkorte titel
Aandoening
complex regional pain syndrome type-1
Ondersteuning
investigator initiated research
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary Objective:
<br><br>
Assessment of a group difference in clinically important improvement in functional outcome of at least 10 points as measured by the DASH questionnaire
Doel van het onderzoek
the active treatment group has an improvement of at least 10 points of DASH functional outcome more than the placebo group.
Onderzoeksopzet
Follow up will be at 1, 3, 6, 9 and 12 months after randomization and start of treatment
Onderzoeksproduct en/of interventie
prednisolon versus placebo
Publiek
Yzabel Vandevivere
Postbus 90151
Tilburg 5000 LC
The Netherlands
y.vandevivere@elisabeth.nl
Wetenschappelijk
Yzabel Vandevivere
Postbus 90151
Tilburg 5000 LC
The Netherlands
y.vandevivere@elisabeth.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5261 |
| NTR-old | NTR5377 |
| CCMO | NL-OSTIN 2015-003 |