Raynaud's Treatment Study (RTS)

NCT ID: NCT00000530

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-09-30
• Study Completion Date: 1998-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

nifedipine

Intervention Type: DRUG

biofeedback (psychology)

Intervention Type: BEHAVIORAL

electromyography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Bruce Thompson

Role:

Clinical Trials & Surveys Corp (C-TASC)

References

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.

Reference Type: BACKGROUND

PMID: 10431945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10789602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11392916 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11104295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11802676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10027500 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

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Document Type: Study Protocol

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Document Type: Study Forms

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Other Identifiers

73

Identifier Type: -

Identifier Source: org_study_id