Clinical Trial: Acupuncture for Women With Stable Angina

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Women With Stable Angina (AIMS-A)

Brief Summary: This pilot study aims to determine if it is possible to perform acupuncture on women diagnosed with stable angina who have symptoms. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.

Detailed Summary: The investigators are conducting a pilot study aimed at gathering feasibility, acceptability, and effect size data for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms in women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for women with stable angina. This study will include 26 community dwelling women with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. The investigators will use a randomized attention control design with 13 women assigned to initial acupuncture and 13 to control. Participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.
Sponsor: University of Illinois at Chicago

Current Primary Outcome:

  • McGill Pain Questionnaire [ Time Frame: before 1st acupuncture treatment of week 1 ]
    The McGill Pain Questionnaire (MPQ) is a well validated and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative pain.
  • McGill Pain Questionnaire [ Time Frame: after the 10th acupuncture treatment of week 10 ]
    The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be. It is a well validated measure of sensory, affective, and evaluative, pain.
  • PAINReportIt® [ Time Frame: before 1st acupuncture treatment of week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.
  • PAINReportIt® [ Time Frame: before 2nd acupuncture treatment of week 1 ]
    PAINReportIt® is an electronic version of the 1970 version of the McGill Pain Questionnaire (MPQ), a valid and reliable measure of pain. The MPQ PAINReportIt captures pain intensity on a 0 to 10 scale where 0 is no pain and 10 is pain as bad as it can be, a well validated measure of pain now, least and worst pain in the past 24 hours.

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: Before first acupuncture treatment of week one ]
      The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability, Angina Frequency, and Quality of Life) measuring the impact of angina on participants' health status. Item responses are coded sequentially from worst to best status and range from 1 to 6 except Quality of Life (range 1-5). Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.
    • Seattle Angina Questionnaire-7 (SAQ-7) [ Time Frame: after the 2nd acupuncture treatment of week 5 ]
      The instrument consists of 7 items in 5 domains (Physical Limitation, Angina Stability,


    Original Secondary Outcome: Same as current

    Information By: University of Illinois at Chicago

    Dates:
    Date Received: August 13, 2016
    Date Started: September 2016
    Date Completion: September 2017
    Last Updated: September 23, 2016
    Last Verified: September 2016