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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Unknown

Conditions: Spinal Cord Injuries

Treatments: Other: Electroacupuncture+Routine rehabilitation training Group; Behavioral: Routine rehabilitation training Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03909958

2019ZZ013

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1.Aged 18-75 years no matter the gender 2.14 days to 3 months after the onset of SCI 3.Patients with cervical, thoracic or lumbar spinal cord injuries 4.SCI classified as B, C, or D grade on the ASIA impairment scale(AIS), that is incomplete SCI (iSCI) 5.Patients with grade 1-3 muscle strength of lower limbs 6.Right-handed 7.Patients who submitted written informed consent

Exclusion Criteria:

1. Contraindication to MRI scanning such as metal in the body, pacemaker
2. Severe structural asymmetry or lesions in the brain
3. Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
4. With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
5. With severe primary diseases such as heart, liver, kidney and hematopoietic system
6. Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
7. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Electroacupuncture+Routine rehabilitation training Group

Other group

Description:

42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training.

Treatment:

Other: Electroacupuncture+Routine rehabilitation training Group

Routine rehabilitation training Group

Other group

Description:

42 patients will receive simple routine rehabilitation training.

Treatment:

Behavioral: Routine rehabilitation training Group