Raynaud's Treatment Study (RTS)

Cardiovascular Diseases Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Raynaud Disease
• Raynaud's Disease
• Vascular Diseases

• NCT number: NCT00000530
• Study type: Interventional
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: Phase 3
• Start date: September 1992
• Completion date: June 1998