Raynaud's Treatment Study (RTS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000530
First received: October 27, 1999
Last updated: June 23, 2005
Last verified: August 2004
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1992
Estimated Study Completion Date: June 1998
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000530

Sponsors and Collaborators
Investigators
Investigator: Bruce Thompson Clinical Trials & Surveys Corp (C-TASC)
  More Information

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:
Raynaud Disease
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Peripheral Vascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014