Raynaud's Treatment Study (RTS)
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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.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Heart Diseases Raynaud's Disease Vascular Diseases |
Drug: nifedipine Behavioral: biofeedback (psychology) Procedure: electromyography |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Primary Purpose: Treatment |
Study Start Date: | September 1992 |
Estimated Study Completion Date: | June 1998 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women with documented primary or secondary Raynaud's syndrome.
Publications:
ClinicalTrials.gov Identifier: | NCT00000530 History of Changes |
Other Study ID Numbers: | 73 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
Cardiovascular Diseases Heart Diseases Raynaud Disease Vascular Diseases Peripheral Vascular Diseases Nifedipine Tocolytic Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on February 24, 2013