Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study

NCT ID: NCT02868671

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-09-30

Brief 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). 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).

Conditions

Acupuncture; Mild Traumatic Brain Injury; MRI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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), 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).

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

sham 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.

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: OTHER

No Intervention

All participants in this study will not receive interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Intervention Type: OTHER

sham acupuncture

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

NSFC81571752

Identifier Type: -

Identifier Source: org_study_id