Acupuncture for Mild Traumatic Brain Injury With Post-traumatic Stress Disorder : A Functional Magnetic Resonance Imaging Study
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|ClinicalTrials.gov Identifier: NCT02868671|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-traumatic Stress Disorders Acupuncture Mild Traumatic Brain Injury||Other: acupuncture Other: sham acupuncture||Not Applicable|
Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI that are reported to be precursors of post-traumatic stress disorder (PTSD), including affective (depression, anxiety) and somatic (headache, sleep difficulties) complaints. Evidence suggests that the increased intensity of these symptoms, particularly greater affective distress and injury-associated pain, increases vulnerability to PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will improve, and, as a result, the incidence of PTSD in this patient population will be reduced.
Research plan: The overarching focus of this study is the use of acupuncture treatment, targeted to symptoms of mild TBI, to reduce the onset of PTSD. The investigators propose a randomized, sham procedure and usual care-controlled clinical trial of acupuncture beginning at acute phase following mild traumatic brain injury (TBI). Participants meeting eligibility requirements will be randomized to 1 of 3 groups: true acupuncture, sham acupuncture or usual care. Acupuncture treatments will continue for one month, at which point all participants will be assessed for presence of mild TBI symptoms, PTSD symptoms, and PTSD diagnosis. Participants will be evaluated again after one-month acupuncture treatment and follow-up post-hospital discharge. The investigators hypothesize that true acupuncture will be more effective than sham acupuncture and usual care in reducing these outcomes at after treatment and follow-up stage. A subgroup of patients were also randomized selected in each group and scanned by 3T MRI scanner at baseline, one-month (after acupuncture treatment) and follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: real acupuncture
Participants will receive treatment four times a week for two weeks and three times a week for two weeks. Participants will be treated with major points: Yintang, Du20 (Bai Hui), LI4 (He Gu), LR3 (Tai Chong), RN4 (Guan Yuan), ST36 (Zusanli) (front treatment) or Du20, GB20 (Feng Chi), SP6 (Sanyinjiao), BL15 (Xin Shu), BL18 (Gan Shu), BL23 (Shen Shu) (back treatment). The position of the treatment will alternate between sessions such that the first session will be on the back, with the next session on the front. In addition to the 6 required points, acupuncturist will be allowed to choose 4 more points. The 4 supplemental points may be chosen from the following: LR2 (Xin Jian), HT7 (Shenmen), PC6 (Neiguan), GB34 (Yang Ling Quan), GB39 (Xuan Zhong), SI3 (Hou Xi), RN6 (Qi Hai), RN24 (Cheng Jiang),KI 3 (Taixi), KI 6 (Zhao Hai), ST40 (Feng Long), SP10 (Xue Hai), BL14 (Jue Yin Shu), BL17 (Ge Shu), BL19 (Dan Shu), BL20 (Pi Shu), BL60 (Kun Lun). Auricular acupuncture will be employed.
Sham Comparator: sham acupuncture
Participants randomized to sham acupuncture will receive a 'placebo' acupuncture session. In the sham procedure, a needle guiding tube will be tapped on the surface of the skin near, but not on, each of the 10 acupuncture points that would have been selected for true acupuncture. The needle guiding tube will be used to create sensations that mimic needle manipulation.
Other: sham acupuncture
No Intervention: No Intervention
All participants in this study will receive usual care. For those assigned to true acupuncture and sham acupuncture, the usual care will be in addition to their acupuncture.
- Changes in responses to the Clinician-Administered post-traumatic stress disorder (PTSD) Scale in patients following acupuncture treatments between baseline and one month [ Time Frame: Baseline, one month ]
- Changes in ratings of Rivermead Post-Concussion Symptom Questionnaire [ Time Frame: Baseline, one month ]
- Diffusion tensor magnetic metrics changes in patients following acupuncture treatment [ Time Frame: baseline, one month ]
- Changes in resting state functional connectivity following acupuncture treatment [ Time Frame: baseline, one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868671
|Contact: Lijun Bai, Ph.Demail@example.com|
|Contact: Ming Zhang, M.Dfirstname.lastname@example.org|
|First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Ming Zhang, M.D email@example.com|
|Principal Investigator:||Ming Zhang, MD||First Affiliated Hospital Xi'an Jiaotong University|