Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Raynaud's Treatment Study (RTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000530
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Raynaud's Disease Vascular Diseases Drug: nifedipine Behavioral: biofeedback (psychology) Procedure: electromyography Phase 3

Detailed Description:


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.


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : September 1992
Study Completion Date : June 1998

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women with documented primary or secondary Raynaud's syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000530

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Layout table for investigator information
OverallOfficial: Bruce Thompson Clinical Trials & Surveys Corp (C-TASC)
Study Data/Documents: Individual Participant Data Set  This link exits the site
Identifier: RTS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.


Layout table for additonal information Identifier: NCT00000530    
Other Study ID Numbers: 73
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: August 2004
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Raynaud Disease
Peripheral Vascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents