Trial Outcomes & Findings for Acupuncture for Individuals With Stable Angina (NCT NCT02914834)
NCT ID: NCT02914834
Last Updated: 2021-10-07
Results Overview
Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Results posted on
2021-10-07
Participant Flow
Participant milestones
| Measure |
Device Acupuncture
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Device Acupuncture
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Overall Study
Study halted due to COVID
|
1
|
1
|
|
Overall Study
1 subject withdrew
|
0
|
1
|
Baseline Characteristics
Acupuncture for Individuals With Stable Angina
Baseline characteristics by cohort
| Measure |
Device Acupuncture
n=12 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=15 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Device Acupuncture
n=12 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=15 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Feasibility of Study Protocol
Participants recruited
|
12 Participants
|
15 Participants
|
|
Feasibility of Study Protocol
Participants retained
|
12 Participants
|
15 Participants
|
|
Feasibility of Study Protocol
Participants completed
|
11 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)Population: Those completing the study protocol at 5 weeks
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.
Outcome measures
| Measure |
Device Acupuncture
n=11 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=13 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Protocol Acceptability Scale for Treating Angina With Acupuncture
|
87.9 percentage of subjects who liked study
|
51.7 percentage of subjects who liked study
|
SECONDARY outcome
Timeframe: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeksAverage 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.
Outcome measures
| Measure |
Device Acupuncture
n=11 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=13 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Average Pain Intensity From the McGill Pain Questionnaire
Baseline Average pain intensity
|
3.81 score on a scale
Standard Deviation 1.99
|
3.42 score on a scale
Standard Deviation 2.56
|
|
Average Pain Intensity From the McGill Pain Questionnaire
Completion Average pain intensity
|
1.21 score on a scale
Standard Deviation 1.13
|
2.97 score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeksThe 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.
Outcome measures
| Measure |
Device Acupuncture
n=11 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=13 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Baseline Functional status
|
16.67 score on a scale
Standard Deviation 15.18
|
29.78 score on a scale
Standard Deviation 26.77
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Completion Functional status
|
46.67 score on a scale
Standard Deviation 27.49
|
16.92 score on a scale
Standard Deviation 19.36
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Baseline symptoms
|
55.00 score on a scale
Standard Deviation 20.23
|
62.67 score on a scale
Standard Deviation 13.35
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Completion Symptoms
|
72.73 score on a scale
Standard Deviation 15.55
|
56.15 score on a scale
Standard Deviation 8.70
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Baseline Quality of Life
|
20.83 score on a scale
Standard Deviation 26.82
|
16.67 score on a scale
Standard Deviation 13.91
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Completion Quality of life
|
54.55 score on a scale
Standard Deviation 23.90
|
11.54 score on a scale
Standard Deviation 12.97
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Baseline Total score
|
29.29 score on a scale
Standard Deviation 13.01
|
36.57 score on a scale
Standard Deviation 16.14
|
|
Seattle Angina Questionnaire-7 (SAQ-7)
Completion Total score
|
56.44 score on a scale
Standard Deviation 19.74
|
27.51 score on a scale
Standard Deviation 9.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeksPopulation: Overall number of participants analyzed differ based on difficulty drawing blood on subjects.
Inflammatory biomarkers between the acupuncture and control group \[interleukin (IL)- 2, IL-4, IL-6, IL-8, IL-10, IL-18; tumor necrosis factor alpha (TNF-α)\]. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.
Outcome measures
| Measure |
Device Acupuncture
n=6 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=11 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Inflammatory Biomarkers Blood Test
Mean Change IL-18
|
55.695 pg/ml
Standard Deviation 65.646
|
16.540 pg/ml
Standard Deviation 68.665
|
|
Inflammatory Biomarkers Blood Test
Mean change IL-2
|
0.394 pg/ml
Standard Deviation 22.523
|
11.595 pg/ml
Standard Deviation 17.414
|
|
Inflammatory Biomarkers Blood Test
Mean Change IL-4
|
-1.444 pg/ml
Standard Deviation 2.724
|
-.818 pg/ml
Standard Deviation 2.306
|
|
Inflammatory Biomarkers Blood Test
Mean Change IL-6
|
-.096 pg/ml
Standard Deviation .863
|
-.212 pg/ml
Standard Deviation 1.224
|
|
Inflammatory Biomarkers Blood Test
Mean Change IL-8
|
2.065 pg/ml
Standard Deviation 7.671
|
1.255 pg/ml
Standard Deviation 5.373
|
|
Inflammatory Biomarkers Blood Test
Mean Change IL-10
|
4.317 pg/ml
Standard Deviation 14.373
|
7.386 pg/ml
Standard Deviation 38.165
|
|
Inflammatory Biomarkers Blood Test
Mean change TNF-alpha
|
6.312 pg/ml
Standard Deviation 25.370
|
8.763 pg/ml
Standard Deviation 20.667
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.Inflammatory biomarker CRP between the acupuncture and control group. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.
Outcome measures
| Measure |
Device Acupuncture
n=6 Participants
Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions
Acupuncture: Standardized acupuncture treatment administered for 30 minutes each session
|
Non-pain Related Video Health Education
n=11 Participants
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.
Non-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
|
|---|---|---|
|
Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)
|
-302.903 ng/ml
Standard Deviation 1049.445
|
-457.205 ng/ml
Standard Deviation 1416.052
|
Adverse Events
Device Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-pain Related Video Health Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place