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Raynaud's Treatment Study (RTS)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000530
Enrollment
Unknown
Registered
1999-10-28
Start date
1992-09-30
Completion date
1998-06-30
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Raynaud's Disease, Vascular Diseases

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.

Interventions

DRUGnifedipine
BEHAVIORALbiofeedback (psychology)
PROCEDUREelectromyography

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026