The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Other: Electroacupuncture+Routine rehabilitation training GroupBehavioral: Routine rehabilitation training Group
- Registration Number
- NCT03909958
- Lead Sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Brief Summary
Spinal cord injury (SCI) is a kind of severe disease with high morbidity and complications. At present, electroacupuncture has certain advantages in treating motor sensory dysfunction, neuropathologic pain, neurogenic bladder and intestinal dysfunction after spinal cord injury. However, previous clinical studies of acupuncture neglected the brain, which is closely related to the structure and function of spinal cord.So,the aim of this study is to observe and analyse the impact of the changes of gray and white matter volume on whole brain and brain functional re-establish,to reveal the neuroimaging mechanism of improving the motor sensory functions of patients with spinal cord injury, and to provide a theoretical basis for the clinical application of electroacupuncture.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
Not provided
- Contraindication to MRI scanning such as metal in the body, pacemaker
- Severe structural asymmetry or lesions in the brain
- Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
- With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
- With severe primary diseases such as heart, liver, kidney and hematopoietic system
- Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture+Routine rehabilitation training Group Electroacupuncture+Routine rehabilitation training Group 42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training. Routine rehabilitation training Group Routine rehabilitation training Group 42 patients will receive simple routine rehabilitation training.
- Primary Outcome Measures
Name Time Method Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI) Before intervention; the end of the 3rd month when treatment finished. The 3D MPRAGE image data collected by fMRI will be recorded and exported on a CD, and then will be processed and analyzed by VBM8.
Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI) Before intervention; the end of the 3rd month when treatment finished. The REST fMRI image data will be recorded and exported to a CD, and then will be processed and analyzed with REST software and seed point method to calculate the ALFF value and FC value of the whole brain.
- Secondary Outcome Measures
Name Time Method Change in Modified Barthel Index(MBI) Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. To assess the ability of the patient to perform daily activities.It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities.Scale range: 0-100.Higher score means better function and less dependence.
Change in ASIA (American Spinal Injury Association) grade Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. To assess the motor function and the sensory function. The motor function will be evaluated according to the scores of five key muscles and muscle strength in both lower limbs.This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-25 for each extremity, with maximum scores of 50 for the upper limbs and 50 for the lower limbs.
The sensory function will be evaluated according to the scores of bilateral pain sensation and tactile sensation in 14 key sensory points in both lower limbs. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-56 points each for light touch and pin prick (sharp/dull discrimination) modalities, with a maximum total score of 112 points per side of the body.Change in Modified Ashworth Scale(MAS) Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. To assess the muscle tone.MAS grades as follows:
0: No increase in muscle tone.1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is(are) moved in flexion or extension.1+: Slight increase in muscle tone, manifested by a catch followed by minimal resistance through the remainder of the range of motion but the affected part(s) is(are) easily moved.2: More marked increase in muscle tone through most of the range of movement, but the affected part(s) is easily moved.3: Considerable increases in muscle tone, passive movement difficult.4: Affected part(s) is (are) rigid in flexion or extension.
Trial Locations
- Locations (1)
The Third Affiliated Hospital of Zhejiang Chinese Medical University
🇨🇳Hangzhou, Zhejiang, China