AcupunctureNCT02868671
Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study
A study testing acupuncture in people with Acupuncture and Mild Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture, Mild Traumatic Brain Injury, MRI
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects presenting to the study hospital emergency department (ED) after sustaining a acute head injury will be eligible if they:
- are aged 18-75 years;
- have a mild TBI, defined by the World Health Organization's Collaborating Centre for Neurotrauma Task Force (2005)
- no contraindications to MR
- injury within 7 days
Who cannot join
- experience with acupuncture treatment
- history of neurological disease, long-standing psychiatric condition, spinal cord injury, head injury, or a history of substance or alcohol abuse
- intubation and/or presence of a skull fracture
- administration of sedatives on arrival in the emergency department,
- the manifestation of mild traumatic brain injury (TBI) due to medications by other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial
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.
Read the detailed description
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).
- Conditions
- Acupuncture, Mild Traumatic Brain Injury, MRI
- Being tested
- acupuncture, sham acupuncture
- Keywords
- mild TBI, post-concussion sydrome, Acupuncture
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
sham acupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| real acupuncture | Experimental | 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). Receives: Other: acupuncture |
| sham acupuncture | Sham comparator | 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. Receives: Other: sham acupuncture |
| No Intervention | No intervention | All participants in this study will not receive interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PCS in patients following acupuncture treatments between baseline and after therapy
Measured: Baseline, after one-month therapy
Secondary outcomes (2)
Changes in PCS in patients following acupuncture treatments between baseline and 6-12 months follow-up
Measured: Baseline, 6-12 months follow-up
Diffusion tensor magnetic metrics changes in patients following acupuncture treatment
Measured: baseline, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868671
- Sponsor's protocol ID
- NSFC81571752
- Status last verified
- Apr 2022
- First submitted
- 21 Jul 2016
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wang ZN, Ding JR, Li X, Shi L, Yin B, Bai GH, Fang M, Lao LX, Tian J, Bai LJ. Acupuncture Improves MRI Brain Microstructure with Postconcussion Symptoms in Mild TBI: A Randomized Controlled Trial. Radiology. 2025 Jul;316(1):e250315. doi: 10.1148/radiol.250315.
PubMed 40693935
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Intervention in Subacute Mild Traumatic Brain Injury With Post-traumatic Stress Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02868671
- Acronym / sponsor ID
- NSFC81571752
- Conditions
- Acupuncture, Mild Traumatic Brain Injury, MRI
- Keywords
- mild TBI, post-concussion sydrome, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University
- Study start
- Aug 2016
- Primary completion
- Aug 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| real acupuncture | Experimental | Other: acupunctureParticipants 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). |
| sham acupuncture | Sham comparator | Other: sham acupunctureParticipants 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. |
| No Intervention | No intervention | –All participants in this study will not receive interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subjects presenting to the study hospital emergency department (ED) after sustaining a acute head injury will be eligible if they:
- are aged 18-75 years;
- have a mild TBI, defined by the World Health Organization's Collaborating Centre for Neurotrauma Task Force (2005)
- no contraindications to MR
- injury within 7 days
Key exclusion criteria (5 listed)
- experience with acupuncture treatment
- history of neurological disease, long-standing psychiatric condition, spinal cord injury, head injury, or a history of substance or alcohol abuse
- intubation and/or presence of a skull fracture
- administration of sedatives on arrival in the emergency department,
- the manifestation of mild traumatic brain injury (TBI) due to medications by other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture | Other | real acupuncture |
| sham acupuncture | Other | sham acupuncture |
Primary outcome
Changes in PCS in patients following acupuncture treatments between baseline and after therapy
Time frame: Baseline, after one-month therapy
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 40693935Wang ZN, Ding JR, Li X, Shi L, Yin B, Bai GH, Fang M, Lao LX, Tian J, Bai LJ. Acupuncture Improves MRI Brain Microstructure with Postconcussion Symptoms in Mild TBI: A Randomized Controlled Trial. Radiology. 2025 Jul;316(1):e250315. doi: 10.1148/radiol.250315.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhang, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acupuncture and Mild Traumatic Brain Injury, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PCS in patients following acupuncture treatments between baseline and after therapy (time frame: Baseline, after one-month therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.