Contact information
Type
Scientific
Primary contact
Dr F.J. Zijlstra
ORCID ID
Contact details
Erasmus Medical Center
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4635606
f.zijlstra@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR571
Study information
Scientific title
Acronym
VasCoTyC study
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
isosorbide dinitrate (ISDN), tadalafil
Primary outcome measures
Tissue blood distribution (thermography and Doppler flow).
Secondary outcome measures
Pain, mobility and quality of life.
Overall trial start date
01/02/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women between 18 and 65 years
2. Established diagnosis of CRPS-1 according to the Bruehl/Budapest criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
76
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Government
Funder name
The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA, USA), Eli Lilly, Ministry of Economic Affairs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18937830
Publication citations
-
Results
Groeneweg G, Huygen FJ, Niehof SP, Wesseldijk F, Bussmann JB, Schasfoort FC, Stronks DL, Zijlstra FJ, Effect of tadalafil on blood flow, pain, and function in chronic cold complex regional pain syndrome: a randomized controlled trial., BMC Musculoskelet Disord, 2008, 9, 143, doi: 10.1186/1471-2474-9-143.