Clinical trial NCT06509841: The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury
Official title: The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Keywords: spinal cord injury
electroacupuncture
Jiaji acupoint
scalp acupuncture
clinical efficacy
Lead sponsor: Hangzhou Medical College
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: ASIA Score
timeFrame: 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)
measure: Modified Barthel Index
timeFrame: 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)
measure: Incidence of Complications
timeFrame: 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.
state: Zhejiang
Study officials:
References:
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