Raynaud's Treatment Study (RTS)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Raynaud's Disease; Cardiovascular Diseases; Vascular Diseases; Heart Diseases

Treatments: Behavioral: biofeedback (psychology); Drug: nifedipine; Procedure: electromyography

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000530

73

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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