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Trial record 5 of 6 for:    acupuncture | TBI | United States

Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01060553
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : November 19, 2014
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
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
Hide 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
[1]
5 subjects completed more than half the sessions and midpoint outcome measures were obtained
Arm/Group Title Arm 1
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title SF-36
Hide Description 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.
Time Frame baseline, 6 or 12 weeks (latest available is used)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1
Hide 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 (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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
mcs pre treatment 35.2  (10.7)
mcs post treatment 39.0  (12.6)
pcs pre treatment 41.2  (9.9)
pcs post treatment 44.5  (9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1
Comments for mcs
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1
Comments for pcs
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .28
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Pittsburgh Sleep Index
Hide Description subscales range from 0 to 3 with higher being worse.
Time Frame baseline, 6 or 12 weeks (latest available is used)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Arm 1
Hide 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.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
sleep duration pre 2.4  (0.7)
sleep duration post 2.1  (0.7)
sleep disturbance pre 2.4  (0.5)
sleep distubance post 1.7  (0.7)
sleep latency pre 2.6  (0.5)
sleep latency post 1.7  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1
Comments for sleep duration
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .34
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1
Comments for sleep disturbance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1
Comments for sleep latency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description due to small numbers of completers in both groups, data from the wait list group who completed subsequent treatment were combined with those initially assigned to treatmen for a pre/post single group analysis
 
Arm/Group Title Arm 1
Hide Arm/Group Description The treatment program will consist 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
All-Cause Mortality
Arm 1
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Arm 1
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1
Affected / at Risk (%)
Total   0/30 (0.00%) 
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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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
Layout table for additonal information
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