Acupressure for the Treatment of Raynaud's Phenomenon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Gladue, DO, University of Michigan
ClinicalTrials.gov Identifier:
NCT01784354
First received: January 18, 2013
Last updated: June 10, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupressure in Raynaud's Phenomenon- A Pilot Study.

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Decrease in number of Raynaud's attacks [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784354

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

No publications provided

Responsible Party: Heather Gladue, DO, Principle Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01784354     History of Changes
Other Study ID Numbers: HUM00062868
Study First Received: January 18, 2013
Last Updated: June 10, 2013
Health Authority: United States: University of Michigan Institution Review Board

ClinicalTrials.gov processed this record on October 01, 2014