Acupuncture for Individuals With Stable Angina

NCT02914834 | Terminated Results DMC

• 2 other identifiers: 2016-0642R21NR017705-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. 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.

Conditions

Angina, Stable; Chest Pain; Microvascular Angina; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Feasibility of Study Protocol

  Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.

  After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

• Protocol Acceptability Scale for Treating Angina With Acupuncture

  Protocol Acceptability Scale for Treating Angina with Acupuncture is a 9-item instrument used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study and did not like acupuncture", and 2 means "liked the study and liked acupuncture". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions in each arm, divided the total score for the 9 questions by the maximum possible points for the measure (18 x number of participants in each arm), and converted the total mean scores to percentage of participants who liked the study/liked acupuncture in each arm.

  After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Secondary Outcomes (2)

• Average Pain Intensity From the McGill Pain Questionnaire

  From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks

• Seattle Angina Questionnaire-7 (SAQ-7)

  From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks

Other Outcomes (2)

• Inflammatory Biomarkers Blood Test

  From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks

• Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)

  From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.

Study Arms (2)

Device Acupuncture

EXPERIMENTAL

Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions

Other: Acupuncture

Non-pain related video health education

ACTIVE COMPARATOR

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.

Other: Non-pain related video health education

Interventions

Acupuncture OTHER

Standardized acupuncture treatment administered for 30 minutes each session

Device Acupuncture

Non-pain related video health education OTHER

Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.

Non-pain related video health education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provision of a verified diagnosis from a care provider
• male or female sex
• at least 21 years of age
• intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body)
• medical confirmation of a diagnosis of stable angina for at least 6 months
• medical confirmation of a diagnosis of chest pain including non-ischemic or ischemic cardiomyopathy
• medical confirmation of a diagnosis of microvascular coronary dysfunction (MCD)
• medical confirmation of a diagnosis of heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF) medical confirmation of chest discomfort.

You may not qualify if:

• pregnancy
• chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms
• autoimmune dysfunction
• use of steroid medications
• concomitant physical therapy
• biofeedback
• massage
• additional acupuncture

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• DeVon HA, Uwizeye G, Cai HY, Shroff AR, Briller JE, Ardati A, Hoppensteadt D, Rountree L, Schlaeger JM. Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population. Acupunct Med. 2022 Apr;40(2):152-159. doi: 10.1177/09645284211055754. Epub 2021 Dec 2.

  PMID: 34856826 DERIVED

MeSH Terms

Conditions

Angina, Stable; Chest Pain; Microvascular Angina; Heart Failure

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Judith Schlaeger, PhD
• Organization: University of Illinois Chicago

jschlaeg@uic.edu

3124134669

Study Officials

• Holli A DeVon, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2016
• First Posted: September 26, 2016
• Study Start: May 15, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)