Raynaud's Treatment Study (RTS)
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Heart Diseases; Raynaud's Disease; Vascular Diseases
Intervention: nifedipine (Drug); biofeedback (psychology) (Behavioral); electromyography (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Bruce Thompson, Affiliation: Clinical Trials and Surveys Corporation
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 Details
Study design: Treatment, Randomized, Placebo Control
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Men and women with documented primary or secondary Raynaud's syndrome.
Locations and Contacts
Additional Information
Related 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.
Starting date: September 1992
Ending date: June 1998
Last updated: June 23, 2005
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