The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT03909958|
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: Electroacupuncture+Routine rehabilitation training Group Behavioral: Routine rehabilitation training Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes in Patients With Spinal Cord Injury:A Randomized Controlled Study Based on Multi-mode MRI|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
Electroacupuncture+Routine rehabilitation training Group
42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training.
Other: Electroacupuncture+Routine rehabilitation training Group
Electroacupuncture： Major acupoints: Jiaji points. With urinary and stool dysfunction:+Shenshu (BL23) ,Huiyang(BL35).
Localization:Jiaji points of the upper 1 and the lower 1 segment of the Spinal cord injury plane, a total of 4 points.
Operation: Insert Jiaji points By using Hwato-brand disposable acupuncture needles(0.30mm*50mm), with 0.5 inch from the median line and a depth of 50 to 60mm with perpendicular insertion.Then, participants will receive electroacupuncture treatment by connecting Han's pain irritant instrument (HANS100A) for 30min with the stimulation frequency of 2 /100 Hz and intensity of 1-2mA. Once a day, 5 days a week and rest 2 days, a week is one course and the duration need 12 courses.
Routine rehabilitation training:
Same as Routine rehabilitation training Group.
Routine rehabilitation training Group
42 patients will receive simple routine rehabilitation training.
Behavioral: Routine rehabilitation training Group
Routine rehabilitation training:
Participants with good spinal stability will receive sitting training as early as possible, and will carry out standing training if participants had no adverse reactions (postural hypotension, etc.) after sitting training. Muscle strength training will be performed in recovery phase, and functional movement training will be selected according to participants' conditions. Functional movement training and transfer training will be performed for 20min each time and once a day;Standing and walking training, 2 times a day, 30min each time.
- Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI) [ Time Frame: 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) [ Time Frame: 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.
- Change in ASIA (American Spinal Injury Association) grade [ Time Frame: 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) [ Time Frame: 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.
- Change in Modified Barthel Index(MBI) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909958
|Contact: Ruijie Ma, Dr.||+86 email@example.com|
|The Third Affiliated Hospital of Zhejiang Chinese Medical University||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Ruijie Ma, Doctor +86 18057102851 firstname.lastname@example.org|
|Contact: Kelin He, Master +86 17764562993|
|Principal Investigator:||Ruijie Ma, Dr.||The Third Affiliated hospital of Zhejiang Chinese Medical University|