530
Last Update Posted: 2016-04-15
Recruiting has ended
All Genders accepted | 18 Years-75 Years |
Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Raynaud's Treatment Study (RTS)
To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.
BACKGROUND:
Primary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers, but may occur in other extremities as well.
DESIGN NARRATIVE:
Randomized. Patients were assigned to one of four treatment groups: slow release Nifedipine, a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph biofeedback from the frontalis muscle. The primary endpoint was reduction in number of vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including frequency, severity, duration, response to laboratory-based cold challenge, and quality of life.
Eligibility
Relevant conditions:
Cardiovascular Diseases
Heart Diseases
Raynaud's Disease
Vascular Diseases
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
locations
Data sourced from ClinicalTrials.gov