Raynaud's Treatment Study (RTS)
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 1992
Typical duration for phase_3 cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
October 27, 1999
CompletedFirst Posted
Study publicly available on registry
October 28, 1999
CompletedApril 15, 2016
August 1, 2004
October 27, 1999
April 14, 2016
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Related Publications (6)
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. doi: 10.1037//0278-6133.18.4.421.
PMID: 10431945BACKGROUNDComparison 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. doi: 10.1001/archinte.160.8.1101.
PMID: 10789602BACKGROUNDBrown 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. doi: 10.1023/a:1010758530555.
PMID: 11392916BACKGROUNDMaricq HR, Jennings JR, Valter I, Frederick M, Thompson B, Smith EA, Hill R; Raynaud's Treatment Study Investigators. 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. doi: 10.1177/1358836X0000500302.
PMID: 11104295BACKGROUNDMiddaugh 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. doi: 10.1023/a:1013182519331.
PMID: 11802676BACKGROUNDThompson 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. doi: 10.1016/s0197-2456(98)00046-4.
PMID: 10027500BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
Bruce Thompson
Clinical Trials & Surveys Corp (C-TASC)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 27, 1999
First Posted
October 28, 1999
Study Start
September 1, 1992
Study Completion
June 1, 1998
Last Updated
April 15, 2016
Record last verified: 2004-08