Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000530
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
1999-10-27
Brief Title:
Raynauds Treatment Study RTS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Raynauds 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 Raynauds phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold andor 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 Raynauds attacks including frequency severity duration response to laboratory-based cold challenge and quality of life
Primary Raynauds phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold andor 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 Raynauds attacks including frequency severity duration response to laboratory-based cold challenge and quality of life
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: