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Acupressure for the Treatment of Raynaud's Phenomenon

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.
 
ClinicalTrials.gov Identifier: NCT01784354
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Heather Gladue, DO, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 18, 2013
First Posted Date  ICMJE February 5, 2013
Last Update Posted Date June 12, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
Decrease in number of Raynaud's attacks [ Time Frame: 1-2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupressure for the Treatment of Raynaud's Phenomenon
Official Title  ICMJE Acupressure in Raynaud's Phenomenon- A Pilot Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Raynaud's Phenomeon
Intervention  ICMJE
  • Other: Acupressure
  • Other: Acupressure dilatation
  • Behavioral: education
Study Arms  ICMJE
  • Placebo Comparator: Education
    target education toward Raynaud's
    Intervention: Behavioral: education
  • Active Comparator: Acupressure
    acupressure- dilatation
    Intervention: Other: Acupressure dilatation
  • Active Comparator: Acupressure relaxation
    acupressure relaxation protocol
    Intervention: Other: Acupressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2013)
36
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784354
Other Study ID Numbers  ICMJE HUM00062868
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heather Gladue, DO, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP