NCT00000530

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1992

Typical duration for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1992

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 15, 2016

Status Verified

August 1, 2004

First QC Date

October 27, 1999

Last Update Submit

April 14, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with documented primary or secondary Raynaud's syndrome.

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: 10431945BACKGROUND
  • 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.

    PMID: 10789602BACKGROUND
  • 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.

    PMID: 11392916BACKGROUND
  • 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.

    PMID: 11104295BACKGROUND
  • 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.

    PMID: 11802676BACKGROUND
  • 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.

    PMID: 10027500BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesRaynaud DiseaseVascular Diseases

Interventions

NifedipineBiofeedback, PsychologyNeurofeedback

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

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