Back to resultsAcupressure for the Treatment of Raynaud's Phenomenon
Primary Purpose
Primary Raynaud's Phenomeon
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure
Acupressure dilatation
education
Sponsored by
About this trial
This is an interventional treatment trial for Primary Raynaud's Phenomeon
Eligibility Criteria
Inclusion Criteria:
- > 18 years old
- Have Raynauds phenomenon, with at least 4 attacks in the last week
- on stable medications
- Willing to attend study visits
Exclusion Criteria:
- smoker
- have a history of stroke, heart attack or irregular heart rhythm
- uncontrolled blood pressure
- physical or mental illness that would interfere with participating in the study
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Education
Acupressure
Acupressure relaxation
Arm Description
target education toward Raynaud's
acupressure- dilatation
acupressure relaxation protocol
Outcomes
Primary Outcome Measures
Decrease in number of Raynaud's attacks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01784354
Brief Title
Acupressure for the Treatment of Raynaud's Phenomenon
Official Title
Acupressure in Raynaud's Phenomenon- A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
5. Study Description
Brief Summary
The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.
Detailed Description
Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Raynaud's Phenomeon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Placebo Comparator
Arm Description
target education toward Raynaud's
Arm Title
Acupressure
Arm Type
Active Comparator
Arm Description
acupressure- dilatation
Arm Title
Acupressure relaxation
Arm Type
Active Comparator
Arm Description
acupressure relaxation protocol
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Type
Other
Intervention Name(s)
Acupressure dilatation
Intervention Type
Behavioral
Intervention Name(s)
education
Primary Outcome Measure Information:
Title
Decrease in number of Raynaud's attacks
Time Frame
1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years old
Have Raynauds phenomenon, with at least 4 attacks in the last week
on stable medications
Willing to attend study visits
Exclusion Criteria:
smoker
have a history of stroke, heart attack or irregular heart rhythm
uncontrolled blood pressure
physical or mental illness that would interfere with participating in the study
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupressure for the Treatment of Raynaud's Phenomenon
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