Clinical trial NCT00000530: Raynaud's Treatment Study (RTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Raynaud's Disease
Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Trials & Surveys Corp (C-TASC)
name: Bruce Thompson
References:
citation: 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.
citation: 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. doi: 10.1001/archinte.160.8.1101.
citation: 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. doi: 10.1023/a:1010758530555.
citation: Maricq 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.
citation: 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. doi: 10.1023/a:1013182519331.
citation: 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. doi: 10.1016/s0197-2456(98)00046-4.