Trial Outcomes & Findings for Acupuncture for PTSD (NCT NCT02869646)
NCT ID: NCT02869646
Last Updated: 2024-04-18
Results Overview
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of \>2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. The minimum score is 0; the maximum score is 80. A higher score is more severe symptoms and a worse outcome. A DSM-5 CAPS cutoff score of \>26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2024-04-18
Participant Flow
Participant milestones
| Measure |
Verum Acupuncture
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
|
Overall Study
COMPLETED
|
39
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for PTSD
Baseline characteristics by cohort
| Measure |
Verum Acupuncture
n=47 Participants
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
n=45 Participants
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
92 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaskan Native
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
23 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · More than one
|
6 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Country of Birth
United States
|
35 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
|
Country of Birth
Other
|
12 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Education Level
HS/GED
|
12 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Education Level
Some College
|
18 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Education Level
College Degree
|
17 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Marital Status
Married
|
24 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Marital Status
Single
|
13 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Marital Status
Divorced
|
8 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Marital Status
Other
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Religion
Buddhist
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Religion
Christian
|
22 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Religion
Muslim
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Religion
Other
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Religion
None
|
12 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Annual Income
Missing
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Annual Income
$0 - $19,999
|
3 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Annual Income
$20,000 - 34,999
|
6 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Annual Income
$35,000 - $49,999
|
13 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Annual Income
>$50,000
|
24 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Employment Status
Yes
|
17 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Employment Status
No
|
30 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Combat Exposure
Light
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Combat Exposure
Moderate Light
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Combat Exposure
Moderate
|
16 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Combat Exposure
Moderate Heavy
|
14 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Combat Exposure
Heavy
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Deployment Preparedness
Low
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Deployment Preparedness
Moderate
|
23 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Deployment Preparedness
High
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: t-tests, statistics of significance and power, and Cohen d tests were used to test hypotheses
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of \>2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. The minimum score is 0; the maximum score is 80. A higher score is more severe symptoms and a worse outcome. A DSM-5 CAPS cutoff score of \>26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
Outcome measures
| Measure |
Verum Acupuncture
n=47 Participants
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
n=45 Participants
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
|---|---|---|
|
Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment
|
22.6 score on a scale
Standard Deviation 14.1
|
29.1 score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: This is only a subset since some either did not participate or dropped out of this component of the research
The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit. The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15). Raw signals will be stored and exported for analysis in microvolt ( V) values.
Outcome measures
| Measure |
Verum Acupuncture
n=28 Participants
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
n=26 Participants
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
|---|---|---|
|
Percentage Change From Baseline in Eyeblink Startle Potentiation
|
-55.8 % change potentiation of startle
Standard Deviation 21.9
|
6.1 % change potentiation of startle
Standard Deviation 19.5
|
Adverse Events
Verum Acupuncture
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Minimal Needling
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verum Acupuncture
n=47 participants at risk
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
n=45 participants at risk
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
|---|---|---|
|
General disorders
SAE
|
0.00%
0/47 • 16 months
Matches government definitions
|
0.00%
0/45 • 16 months
Matches government definitions
|
Other adverse events
| Measure |
Verum Acupuncture
n=47 participants at risk
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Acupuncture: Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
|
Minimal Needling
n=45 participants at risk
shallow and non-acupoint needles at same number of sites
Procedure: Sham acupuncture: Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
|
|---|---|---|
|
Blood and lymphatic system disorders
abnormal labs
|
14.9%
7/47 • 16 months
Matches government definitions
|
8.9%
4/45 • 16 months
Matches government definitions
|
|
Nervous system disorders
Emotional Distress
|
12.8%
6/47 • 16 months
Matches government definitions
|
8.9%
4/45 • 16 months
Matches government definitions
|
|
Musculoskeletal and connective tissue disorders
ED visit for pain
|
6.4%
3/47 • 16 months
Matches government definitions
|
0.00%
0/45 • 16 months
Matches government definitions
|
|
General disorders
ED visit other
|
4.3%
2/47 • 16 months
Matches government definitions
|
4.4%
2/45 • 16 months
Matches government definitions
|
|
General disorders
General medial symptoms
|
19.1%
9/47 • 16 months
Matches government definitions
|
8.9%
4/45 • 16 months
Matches government definitions
|
|
Nervous system disorders
PTSD severe related
|
8.5%
4/47 • 16 months
Matches government definitions
|
4.4%
2/45 • 16 months
Matches government definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place