The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- ASIA Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Scalp electro-acupuncture
Recruiting patients receiving electro-acupuncture at the Scalp points
干预措施: Electro-acupuncture at the scalp points (Other)
Jiaji electro-acupuncture
Recruited patients receiving electro-acupuncture at the Jiaji points
干预措施: Electro-acupuncture at the Jiaji points (Other)
结局指标
主要结局
ASIA Score
时间窗: 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
时间窗: 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
时间窗: 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%.
次要结局
未报告次要终点