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van CCT (UK)

van CCT (UK)

Oral steroids for the treatment of inflammatory CRPS-1

- candidate number22812
- NTR NumberNTR5377
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2015
- Secondary IDs NL-OSTIN 2015-003 
- Public TitleOral steroids for the treatment of inflammatory CRPS-1
- Scientific Titleoral steroids for the treatment of inflammatory CRPS-1
- hypothesisthe active treatment group has an improvement of at least 10 points of DASH functional outcome more than the placebo group.
- Healt Condition(s) or Problem(s) studiedComplex Regionaal Pain Syndrome (CRPS)
- Inclusion criteria1. 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 criteria1. 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 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-okt-2018
- Target number of participants52
- Interventionsprednisolon versus placebo
- Primary outcomePrimary 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 outcomeSecondary 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
- TimepointsFollow up will be at 1, 3, 6, 9 and 12 months after randomization and start of treatment
- Trial web siteNA
- statusplanned
- Sponsor/Initiator Investigator initiated trial ( IIT )
- Funding
(Source(s) of Monetary or Material Support)
Stichting Esperance
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-aug-2015 - 6-okt-2015

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