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

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01060553
First received: January 29, 2010
Last updated: November 7, 2014
Last verified: November 2014
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Post-traumatic Stress Disorders
Intervention: Other: Acupuncture treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Active Treatment     Wait List Control  
STARTED     15     15  
COMPLETED     6 [1]   5  
NOT COMPLETED     9     10  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 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

Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Gender  
[units: participants]
 
Female     9  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   SF-36   [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ]

2.  Secondary:   Pittsburgh Sleep Index   [ Time Frame: baseline, 6 or 12 weeks (latest available is used) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
e-mail: thomas.findley@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01060553     History of Changes
Other Study ID Numbers: PPO 09-258
Study First Received: January 29, 2010
Results First Received: October 15, 2014
Last Updated: November 7, 2014
Health Authority: United States: Federal Government