Clinical Prognostic Study on Acupuncture Intervention for Traumatic Spinal Cord Injury
NCT Number: NCT06509841
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Traumatic Spinal Cord Injury
Interventions: OTHER: conventional rehabilitation treatment|OTHER: Acupuncture treatment rehabilitation
Sponsor: Hangzhou Medical College
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-01-01
Completion Date: 2021-09-30
Locations: the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College., Hangzhou, Zhejiang, 311000, China

Summary:
Patients with traumatic spinal cord injury were divided into acupuncture treatment rehabilitation group and conventional rehabilitation treatment group, with 42 people in each group. After treatment, their clinical efficacy was evaluated.

Primary Outcome Measures: ASIA level, The ASIA Spinal Cord Injury Score, developed by the American Spinal Cord Injury Association, assesses the severity of spinal cord injury and functional recovery through evaluations of neuromotor performance, light touch function, pin prick function, and sphincter function. This scoring system categorizes spinal cord injuries into five levels: Level 1/A, Level 2/B, Level 3/C, Level 4/D, and Level 5/E. Lower grades indicate more severe injuries, resulting in weaker motor, light touch function, and pinprick sense function scores., 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)|ASIA motor function score, The ASIA Spinal Cord Injury Score, developed by the American Spinal Cord Injury Association, assesses the severity of spinal cord injury and functional recovery through evaluations of neuromotor performance, light touch function, pin prick function, and sphincter function. This scoring system categorizes spinal cord injuries into five levels: Level 1/A, Level 2/B, Level 3/C, Level 4/D, and Level 5/E. Lower grades indicate more severe injuries, resulting in weaker motor, light touch function, and pinprick sense function scores., 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)|ASIA Acupuncture Sensory Function Score, The ASIA Spinal Cord Injury Score, developed by the American Spinal Cord Injury Association, assesses the severity of spinal cord injury and functional recovery through evaluations of neuromotor performance, light touch function, pin prick function, and sphincter function. This scoring system categorizes spinal cord injuries into five levels: Level 1/A, Level 2/B, Level 3/C, Level 4/D, and Level 5/E. Lower grades indicate more severe injuries, resulting in weaker motor, light touch function, and pinprick sense function scores., 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)|ASIA Light Touch Function Score, The ASIA Spinal Cord Injury Score, developed by the American Spinal Cord Injury Association, assesses the severity of spinal cord injury and functional recovery through evaluations of neuromotor performance, light touch function, pin prick function, and sphincter function. This scoring system categorizes spinal cord injuries into five levels: Level 1/A, Level 2/B, Level 3/C, Level 4/D, and Level 5/E. Lower grades indicate more severe injuries, resulting in weaker motor, light touch function, and pinprick sense function scores., 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)|MBI, The Modified Barthel Index Rating Scale is utilized to evaluate the capability of adults in performing daily living activities. It consists of 10 assessment items such as eating, bathing, grooming, dressing, and managing bowel and bladder functions, each with varying levels. The total score is 100 points, with a score of ≥60 indicating mild dysfunction, 59-41 indicating moderate dysfunction, and ≤40 indicating severe dysfunction., 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)|Incidence of complications, Observe the development of severe bleeding, pressure ulcers, deep vein thrombosis, neurogenic bowel dysfunction, neurogenic bladder, kidney disease, lung infection, traumatic encephalopathy, pain, and other complications during treatment and follow-up. Record the various types of complications and the number of people affected. Calculate the complication rate using the formula: Complication rate = (total number of cases of such complications in each group) ÷ (total number of patients in this group) × 100%., before treatment, during treatment, after treatment, and 3 months of follow-up (3 months after the end of treatment)