Vasodilators in cold type Complex Regional Pain Syndrome
| ISRCTN | ISRCTN60226869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60226869 |
| Protocol serial number | NTR571 |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA, USA), Eli Lilly, Ministry of Economic Affairs |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | isosorbide dinitrate (ISDN), tadalafil |
| Primary outcome measure(s) |
Tissue blood distribution (thermography and Doppler flow). |
| Key secondary outcome measure(s) |
Pain, mobility and quality of life. |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
