Trial record 5 of 6 for:
acupuncture | TBI | United States
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
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| ClinicalTrials.gov Identifier: NCT01060553 |
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Recruitment Status :
Completed
First Posted : February 2, 2010
Results First Posted : November 19, 2014
Last Update Posted : April 28, 2015
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Sponsor:
US Department of Veterans Affairs
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Post-traumatic Stress Disorders |
| Intervention |
Other: Acupuncture treatment |
| Enrollment | 34 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 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. |
| Arm/Group Title | Active Treatment | Wait List Control |
|---|---|---|
 Arm/Group Description |
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. |
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 |
| Period Title: Overall Study | ||
| Started | 15 | 15 |
| Completed | 6 [1] | 5 |
| Not Completed | 9 | 10 |
| Reason Not Completed | ||
| Lost to Follow-up | 3 | 5 |
| Withdrawal by Subject | 5 | 5 |
| Lack of Efficacy | 1 | 0 |
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[1]
5 subjects completed more than half the sessions and midpoint outcome measures were obtained
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Baseline Characteristics
| Arm/Group Title | Arm 1 | |
|---|---|---|
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Arm/Group Description |
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 | |
| Overall Number of Baseline Participants | 30 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 30 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
30 100.0%
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| >=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 30 participants | |
| Female |
9 30.0%
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| Male |
21 70.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 30 participants |
| 30 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
very small numbers of subjects due to dropout and loss to followup. data from the wait list subjects who completed the intervention were combined with those initially assigned to treatment for a pre/post single group analysis
More Information
Results Point of Contact
| Name/Title: | Thomas W. Findley, MD, PhD |
| Organization: | Veteran Affairs New Jersey Health Care System |
| Phone: | 973-676-1000 ext 2713 |
| EMail: | thomas.findley@va.gov |
| Responsible Party: | VA Office of Research and Development ( US Department of Veterans Affairs ) |
| ClinicalTrials.gov Identifier: | NCT01060553 |
| Other Study ID Numbers: |
PPO 09-258 |
| First Submitted: | January 29, 2010 |
| First Posted: | February 2, 2010 |
| Results First Submitted: | October 15, 2014 |
| Results First Posted: | November 19, 2014 |
| Last Update Posted: | April 28, 2015 |