An interventional study of acupuncture and sham acupuncture in Acupuncture, Mild Traumatic Brain Injury and MRI, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
The overall goal of this study is to examine if acupuncture intervention can reduce the post-concussion symptom (PCS), and affective and cognitive complaints among mild traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham acupuncture and waiting list control groups, patients in the real acupuncture group will have fewer symptoms of depression, sleep problems and post-concussion symptoms.
Project Background: Acupuncture has been shown in other settings to alleviate symptoms of TBI that are reported to be precursors of post-concussion symptom, 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 neurodegenerative disease and PTSD. By treating post-TBI symptoms with acupuncture, these predisposing conditions will improve, and, as a result, the incidence of PCS 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. 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: verum acupuncture, sham acupuncture or waiting-list control. Acupuncture treatments will continue for one month, at which point all participants will be assessed for presence of mild TBI symptoms. 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 in reducing these outcomes at after treatment and follow-up stage. Patients were also scanned by 3T MRI scanner at baseline, one-month (after acupuncture treatment).
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 66 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
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), ST36 (Zusanli) (front treatment) or 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 5 required points, acupuncturist will be allowed to choose 1-3 more points. The supplemental points may be chosen from the following: HT7 (Shenmen), PC6 (Neiguan), SI3 (Hou Xi), RN6 (Qi Hai), KI 3 (Taixi), KI 6 (Zhao Hai), SP10 (Xue Hai), BL14 (Jue Yin Shu), BL17 (Ge Shu), BL20 (Pi Shu).
Other: acupuncture
Participants randomized to sham acupuncture will receive a 'placebo' acupuncture session. For sham acupuncture, Streitberger needles, which acted like stage dagger with the shaft of the needle retracting into the handle, were placed at non-acupuncture points with the same number of acupuncture points in the VA group. The needle guiding tube will be used to create sensations that mimic needle manipulation.
Other: sham acupuncture
All participants in this study will not receive interventions.
Changes in PCS in patients following acupuncture treatments between baseline and after therapy
Time frame: Baseline, after one-month therapy
Changes in PCS in patients following acupuncture treatments between baseline and 6-12 months follow-up
Time frame: Baseline, 6-12 months follow-up
Diffusion tensor magnetic metrics changes in patients following acupuncture treatment
Time frame: baseline, one month
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University