Vasodilators in cold type Complex Regional Pain Syndrome
| ISRCTN | ISRCTN60226869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60226869 |
| Secondary identifying numbers | NTR571 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 08/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.J. Zijlstra
Scientific
Scientific
Erasmus Medical Center
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4635606 |
|---|---|
| f.zijlstra@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | VasCoTyC study |
| Study objectives | Nitric oxide dependent and independent vasodilation in patients with disused, cold type CRPS, will regenerate blood tissue distribution and consequently improve mobility and quality of life factors. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cold type complex regional pain syndrome (CRPS) |
| Intervention | Subjects are assigned to receive either 1 g isosorbide dinitrate (ISDN) ointment 1% or placebo 4 times daily (groups 1 and 2) or 1 tablet of 10 mg tadalafil or placebo daily (groups 3 and 4). The treatment period will be 10 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | isosorbide dinitrate (ISDN), tadalafil |
| Primary outcome measure | Tissue blood distribution (thermography and Doppler flow). |
| Secondary outcome measures | Pain, mobility and quality of life. |
| Overall study start date | 01/02/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 76 |
| Key inclusion criteria | 1. Men and women between 18 and 65 years 2. Established diagnosis of CRPS-1 according to the Bruehl/Budapest criteria |
| Key exclusion criteria | 1. Coronary atherosclerosis or cerebral sclerosis 2. Recent heart infarction 3. Increased intracranial pressure 4. Severe hypotension 5. Myocardium insufficiency 6. Damage of the central nervous system 7. Contraindication of nitrates 8. Inflammation of joints 9. Use of corticosteroids or immunosuppressives 10. Unable to fill in questionnaires |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Not defined
Not defined
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Government
The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA, USA), Eli Lilly, Ministry of Economic Affairs
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/10/2008 | Yes | No |
