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

May 4, 2025 updated by: Hangzhou Medical College

The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311000
        • the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scalp electro-acupuncture
Recruiting patients receiving electro-acupuncture at the Scalp points
Other: Electro-acupuncture at the scalp points
Adopting treatments for the group that received electro-acupuncture at the Scalp points, including: ① electro-acupuncture at the Scalp points with continuous treatment for 8 weeks.
Experimental: Jiaji electro-acupuncture
Recruited patients receiving electro-acupuncture at the Jiaji points
Other: Electro-acupuncture at the Jiaji points
Adopting treatments for the group that received electro-acupuncture at the Jiaji points, including: ① electro-acupuncture at the Jiaji points with continuous treatment for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASIA Score
Time Frame: 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.
0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)
Modified Barthel Index
Time Frame: 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.
0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)
Incidence of Complications
Time Frame: 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%.
0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

July 6, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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