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Clinical Trial: Raynaud's Treatment Study (RTS)
This study has been completed.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Cardiovascular Diseases Heart Diseases Raynaud's Disease Vascular Diseases | Drug: nifedipine Behavior: biofeedback (psychology) Procedure: electromyography | Phase III |
MedlinePlus related topics: Heart Diseases; Heart Diseases--Prevention; Raynaud's Disease; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control
Study start: September 1992; Study completion: June 1998
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 - 75 Years, Genders Eligible for Study: Both
Criteria
Location Information
Bruce Thompson, Clinical Trials and Surveys Corporation
More Information
Publications
Thompson B, Geller NL, Hunsberger S, Frederick M, Hill R, Jacob RG, Smith EA, Kaufmann P, Freedman RR, Wigley FM, Bielory L. Behavioral and pharmacologic interventions: the Raynaud's Treatment Study. Control Clin Trials. 1999 Feb;20(1):52-63.
Jennings JR, Maricq HR, Canner J, Thompson B, Freedman RR, Wise R, Kaufmann PG. A thermal vascular test for distinguishing between patients with Raynaud's phenomenon and healthy controls. Raynaud's Treatment Study Investigators. Health Psychol. 1999 Jul;18(4):421-6.
[No authors listed] Comparison of sustained-release nifedipine and temperature biofeedback for treatment of primary Raynaud phenomenon. Results from a randomized clinical trial with 1-year follow-up. Arch Intern Med. 2000 Apr 24;160(8):1101-8.
Brown KM, Middaugh SJ, Haythornthwaite JA, Bielory L. The effects of stress, anxiety, and outdoor temperature on the frequency and severity of Raynaud's attacks: the Raynaud's Treatment Study. J Behav Med. 2001 Apr;24(2):137-53.
Maricq HR, Jennings JR, Valter I, Frederick M, Thompson B, Smith EA, Hill R. Evaluation of treatment efficacy of Raynaud phenomenon by digital blood pressure response to cooling. Raynaud's Treatment Study Investigators. Vasc Med. 2000;5(3):135-40.
Middaugh SJ, Haythornthwaite JA, Thompson B, Hill R, Brown KM, Freedman RR, Attanasio V, Jacob RG, Scheier M, Smith EA. The Raynaud's Treatment Study: biofeedback protocols and acquisition of temperature biofeedback skills. Appl Psychophysiol Biofeedback. 2001 Dec;26(4):251-78.
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: October 27, 1999
ClinicalTrials.gov Identifier: NCT00000530
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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