Condition category
Musculoskeletal Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

Not defined

Website

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

  1. 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.

Additional files

Editorial Notes