The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries (SCI)
• Interventions: Other: conventional rehabilitation treatment; Other: Acupuncture treatment rehabilitation

• Registration Number: NCT06509841
• Lead Sponsor: Hangzhou Medical College

Brief Summary

Spinal cord injury (SCI), leads to functional deficits and complications like neurogenic bladder and deep vein thrombosis, imposing a global annual financial burden. This trial aims to compares Jiaji electroacupuncture (JEA) and scalp electroacupuncture (SEA) in SCI rehabilitation. This randomized controlled trial (RCT) compared JEA and SEA in SCI rehabilitation.

Detailed Description

The motor function score, light touch score, and pinprick sensation score of both groups showed significant improvement ( P \< 0.001). When comparing Group A and Group B, there was no statistically significant difference in ASIA grade improvement at week 4 ( P \> 0.05), but at week 8 and the 3-month follow-up, the proportion of ASIA grade improvement in Group A was significantly higher than that in Group B (week 8: 40.48% vs. 14.29%, P=0.007; 3-month follow-up: 47.62% vs. 21.43%, P = 0.012). At week 4, week 8, and the 3-month follow-up, Group A's motor function score, light touch score, pinprick sensation score, and MBI were all higher than those of Group B ( P \< 0.05).

Study Timeline

• Status Verified: 2022-07
• Study Start: 2024-05-01
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-14
• Study First Posted: 2024-07-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-30
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. The duration of spinal cord injury must be between 3 to 6 months;
2. The site of injury must be clearly defined;
3. The cause of injury must be traumatic;
4. Patients must be over 18 years of age;
5. Patients must provide consent to participate in this study.

Exclusion Criteria

1. Unknown time or site of injury;
2. Disagreement to participate in this study;
3. Patients with contraindications for acupuncture intervention (such as skin lesions or rashes at potential acupuncture sites);
4. Patients with cognitive or language impairments who are unable to cooperate with scale evaluations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture treatment rehabilitation group	conventional rehabilitation treatment	Routine rehabilitation treatment combined with acupuncture and moxibustion treatment, the acupuncture measures taken are mainly Dumai points. Once a day. 5 times a week, continuous treatment for 4 weeks.
Acupuncture treatment rehabilitation group	Acupuncture treatment rehabilitation	Routine rehabilitation treatment combined with acupuncture and moxibustion treatment, the acupuncture measures taken are mainly Dumai points. Once a day. 5 times a week, continuous treatment for 4 weeks.
Conventional rehabilitation treatment group	conventional rehabilitation treatment	Adopting conventional rehabilitation training methods for TSCI patients, including: ① posture training; ②Joint rehabilitation training; ③Breathing training; ④Muscle strength training, 7 times a week, with continuous treatment for 4 weeks.

Primary Outcome Measures

Name	Time	Method
ASIA Score	0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)	The ASIA score for spinal cord injury, established by the American Spinal Injury Association, serves as a method to assess the severity of spinal cord injuries and functional recovery. It includes evaluations of the patient's neurological motor function, light touch sensation score, pinprick sensation score, and sphincter function performance. The ASIA score categorizes spinal cord injuries into five grades: 1/A, 2/B, 3/C, 4/D, and 5/E. A lower grade indicates a more severe injury, characterized by weaker motor and sensory scores, including light touch and pinprick sensation scores.
Modified Barthel Index	0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)	The Modified Barthel Index Rating Scale is a tool used to assess adults' abilities to perform activities of daily living. It comprises 10 assessment items, including feeding, bathing, grooming, dressing, and controlling bowel and bladder movements. Each item is divided into different levels corresponding to various scores, with a maximum score of 100. A score of ≥60 indicates mild functional impairment, a score of 59-41 indicates moderate functional impairment, and a score of ≤40 indicates severe functional impairment.
Incidence of Complications	0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)	Monitor whether patients experience severe bleeding, pressure ulcers, deep vein thrombosis, neurogenic bowel dysfunction, neurogenic bladder, nephropathy, pulmonary infections, traumatic encephalopathy, pain, and other complications during the treatment and follow-up periods. Record the number of patients with each type of complication. The incidence rate of complications is calculated as follows: (Total number of cases with a specific complication in each group) ÷ (Total number of patients in that group) × 100%.

Trial Locations

Locations (1)

the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.; 🇨🇳 Hangzhou, Zhejiang, China