Trial Outcomes & Findings for Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD (NCT NCT01060553)
NCT ID: NCT01060553
Last Updated: 2015-04-28
Results Overview
global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
baseline, 6 or 12 weeks (latest available is used)
Results posted on
2015-04-28
Participant Flow
34 subjects were interviewed for consent. 15 were assigned to immediate treatment. 15 were assigned to wait list treatment. 2 did not meet inclusion criteria. 2 were assigned to case study.
Participant milestones
| Measure |
Active Treatment
The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used.
|
Wait List Control
this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Active Treatment
The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used.
|
Wait List Control
this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
Baseline characteristics by cohort
| Measure |
Arm 1
n=30 Participants
24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 or 12 weeks (latest available is used)Population: due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.
global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.
Outcome measures
| Measure |
Arm 1
n=11 Participants
The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment
|
|---|---|
|
SF-36
mcs pre treatment
|
35.2 units on a scale
Standard Deviation 10.7
|
|
SF-36
mcs post treatment
|
39.0 units on a scale
Standard Deviation 12.6
|
|
SF-36
pcs pre treatment
|
41.2 units on a scale
Standard Deviation 9.9
|
|
SF-36
pcs post treatment
|
44.5 units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: baseline, 6 or 12 weeks (latest available is used)Population: due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis
subscales range from 0 to 3 with higher being worse.
Outcome measures
| Measure |
Arm 1
n=11 Participants
The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment
|
|---|---|
|
Pittsburgh Sleep Index
sleep duration pre
|
2.4 units on a scale
Standard Deviation 0.7
|
|
Pittsburgh Sleep Index
sleep duration post
|
2.1 units on a scale
Standard Deviation 0.7
|
|
Pittsburgh Sleep Index
sleep disturbance pre
|
2.4 units on a scale
Standard Deviation 0.5
|
|
Pittsburgh Sleep Index
sleep distubance post
|
1.7 units on a scale
Standard Deviation 0.7
|
|
Pittsburgh Sleep Index
sleep latency pre
|
2.6 units on a scale
Standard Deviation 0.5
|
|
Pittsburgh Sleep Index
sleep latency post
|
1.7 units on a scale
Standard Deviation 1.2
|
Adverse Events
Arm 1
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
Thomas W. Findley, MD, PhD
Veteran Affairs New Jersey Health Care System
Phone: 973-676-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place