Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Official title

The Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis

Overview

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

This study employed a randomized controlled clinical trial method to compare the effects of JEA and SEA interventions on the clinical outcomes of patients with traumatic spinal cord injury (TSCI). The findings revealed that, compared to SEA, JEA intervention demonstrated superior performance in improving patients' ASIA grading, motor function scores, light touch sensation scores, pinprick sensation scores, and modified Barthel index. This indicates that JEA has a significant advantage in promoting the enhancement of ASIA grading, recovery of motor and sensory function scores, and improvement in daily living activities among TSCI patients. The conclusions of this study further substantiate the positive role of JEA in ameliorating motor function, sensory function scores, and daily living conditions in patients with spinal cord injury.

Interventions

• Procedure Conventional treatment
  Patients will randomly assigned to routine treatment group (control group) and individualized treatment model group (intervention group). All patients will observed and intervened for 4 months. Patients in the control treatment group will follow the treatment plan in the 2016SOSORT guidelines
• Behavioral intervention treatment
  Patients will be input into the health management platform. The optimal treatment scheme will be then determined through data calculation and sent to individuals (or their families) or schools for implementation under the guidance of the platform. It is important to note that the specific treatment plan varied from person to person. Patients were observed and intervened for a period of 4 months. 1. Massage therapy 2. Posture guidance 3. Schroeder\'s gymnastics therapy 4. Bioelectric stimula

Primary outcome measures

• Number of Cobb angles [Time frame: 4 months before the intervention and 4 months after the intervention]
• Accuracy of new screening modalities [Time frame: 4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention]
• Hamilton Depression Volume [Time frame: 4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention]

Eligibility criteria

Inclusion criteria

• The diagnosis of moderate and mild AIS, with a Cobb angle measuring less than 45°;
• The age range of 12 to 16 years old;
• Participants are required to have no history of mental illness, possess normal communication skills, and be proficient in reading and writing;
• Signed informed consent by the patient or their family.

Exclusion criteria

Patients who fulfill any of the following conditions will be excluded a clear history of inducement, such as diseases caused by trauma, surgery, cognitive impairment, severe dysfunction of heart, liver, kidney and other organs, and malignant tumors, immune diseases and other malignant diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

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

Identifiers

NCT: NCT06314594 · 2024KY920

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗