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Acupressure for the Treatment of Raynaud's Phenomenon

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01784354
First Posted: February 5, 2013
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heather Gladue, DO, University of Michigan
  Purpose
The use of acupressure will be compared to targeted Raynaud's education and will evaluate the` frequency, duration and pain of Raynaud's attacks.

Condition Intervention
Primary Raynaud's Phenomeon Other: Acupressure Other: Acupressure dilatation Behavioral: education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupressure in Raynaud's Phenomenon- A Pilot Study.

Further study details as provided by Heather Gladue, DO, University of Michigan:

Primary Outcome Measures:
  • Decrease in number of Raynaud's attacks [ Time Frame: 1-2 years ]

Enrollment: 23
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Education
target education toward Raynaud's
Behavioral: education
Active Comparator: Acupressure
acupressure- dilatation
Other: Acupressure dilatation
Active Comparator: Acupressure relaxation
acupressure relaxation protocol
Other: Acupressure

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784354


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Heather Gladue, DO, Principle Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01784354     History of Changes
Other Study ID Numbers: HUM00062868
First Submitted: January 18, 2013
First Posted: February 5, 2013
Last Update Posted: June 12, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases