Cardiovascular Diseases Clinical Trial
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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