NCT03909958

The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-11-26
• Primary completion: 2020-12-31
• Completion: 2021-08-31
• First posted: 2019-04-10
• Last updated: 2020-09-17

Locations

1 site across 1 country: China