Vasodilators in cold type Complex Regional Pain Syndrome.

A double blind, randomized, placebo controlled trial of isosorbide dinitrate and tadalafil in cold type complex regional pain syndrome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27167

Enrollment

Registered

2006-01-20

Start date

2006-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold type complex regional pain syndrome

Interventions

Subjects are assigned to receive either 1 gram ISDN ointment 1% or placebo 4 times daily (groups 1 and 2) or 1 tablet of 10 mg tadalafil or palcebo daily (groups 3 and 4). The treatment period will be

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women between 18 and 65 years; 2. Established diagnosis of CRPS-1 according to the Bruehl / Budapest criteria.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Tissue blood distribution (thermography and Doppler flow).	—

Secondary

Measure	Time frame
Pain, mobility and quality of life.	—

Contacts

Public ContactF.J. Zijlstra

Erasmus Medical Center, Department of Anesthesiology, P.O. Box 2040

f.zijlstra@erasmusmc.nl+31 (0)10 4635606

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)