Angina, StableAIMS-ANCT02914834
Acupuncture for Individuals With Stable Angina
A study testing Acupuncture and Non-pain related video health education in people with Angina, Stable and Chest Pain, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Angina, Stable, Chest Pain, Microvascular Angina
- What is being tested?
- Acupuncture and Non-pain related video health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnancy
- chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms
- autoimmune dysfunction
- use of steroid medications
- concomitant physical therapy
- biofeedback
- massage
- additional acupuncture
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Nursing
Chicago, Illinois, 60612
About this study
Official title: Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
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.
Read the detailed description
The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (MCD), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), or chest discomfort 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 men and 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.
- Conditions
- Angina, Stable, Chest Pain, Microvascular Angina, Heart Failure
- Being tested
- Acupuncture, Non-pain related video health education
- Medical subject headings
- Angina, Stable, Chest Pain, Microvascular Angina, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Standardized acupuncture treatment administered for 30 minutes each session
Non-pain related video health educationOther
Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
| Study group | Role | What they receive |
|---|---|---|
| Device Acupuncture | Experimental | Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions Receives: 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. Receives: Other: Non-pain related video health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Study Protocol
Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.
Measured: 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.
Measured: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Secondary outcomes (2)
Average Pain Intensity From the McGill Pain Questionnaire
Average Pain Intensity from the McGill Pain Questionnaire is the average of pain now, least pain in the past 24 hours, and worst pain in the past 24 hours. Average Pain Intensity is scored on a 0 to 10 Likert type scale with 0 = no pain and 10 = excruciating pain. Pain intensity is the pre-specified outcome measure, while pain now and least and worst pain are values used to calculate average pain intensity and were not specified outcome measures.
Measured: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Seattle Angina Questionnaire-7 (SAQ-7)
The instrument consists of 7 items measuring functional status, symptoms, and quality of life on participants. 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.
Measured: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start15 May 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Research activity halted due to the Coronavirus Disease 2019 (COVID-19) pandemic. We were obliged to stop the in-person study in March 2020 due to the mandated lockdowns as a result of COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Judith Schlaeger, University of Illinois Chicago
- Investigators
- Holli A DeVon, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914834
- Sponsor's protocol ID
- 2016-0642
- Other IDs
- R21NR017705-01A1
- Acronym
- AIMS-A
- Status last verified
- Oct 2021
- First submitted
- 13 Aug 2016
- Last updated
- 7 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34856826
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)
- ClinicalTrials.gov ID
- NCT02914834
- Acronym / sponsor ID
- AIMS-A / 2016-0642
- Conditions
- Angina, Stable, Chest Pain, Microvascular Angina, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research activity halted due to the Coronavirus Disease 2019 (COVID-19) pandemic. We were obliged to stop the in-person study in March 2020 due to the mandated lockdowns as a result of COVID.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (MCD), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), or chest discomfort 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 men and 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Acupuncture | Experimental | Other: AcupunctureStandardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions |
| Non-pain related video health education | Active comparator | Other: Non-pain related video health educationThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- pregnancy
- chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms
- autoimmune dysfunction
- use of steroid medications
- concomitant physical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureStandardized acupuncture treatment administered for 30 minutes each session | Other | Device Acupuncture |
| Non-pain related video health educationAttention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion. | Other | Non-pain related video health education |
Primary outcome
Feasibility of Study Protocol
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.
Protocol Acceptability Scale for Treating Angina With Acupuncture
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
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.
2 secondary outcomes
Average Pain Intensity From the McGill Pain Questionnaire
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Seattle Angina Questionnaire-7 (SAQ-7)
Time frame: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34856826DeVon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holli A DeVon, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Non-pain related video health education in people with Angina, Stable and Chest Pain, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study Protocol (time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.