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NCT Number: NCT06509841

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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.

Hangzhou, Zhejiang, 311000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electro-acupuncture at the Jiaji points

Other

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.

Electro-acupuncture at the scalp points

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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%.

Sponsors and collaborators

Lead sponsor

Hangzhou Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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