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.

Completed

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Key information

Conditions

Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Raynaud's Disease Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Men and women with documented primary or secondary Raynaud's syndrome.

Treatment and study plan

nifedipine

Drug

biofeedback (psychology)

Behavioral

Electromyography

Procedure

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 1992
Study completion: 1998
First posted: Oct 28, 1999
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed