NCT06314594

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

March 11, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

spinal cord injury; electroacupuncture; Jiaji acupoint; scalp acupuncture; clinical efficacy

Outcome Measures

Primary Outcomes (3)

  • Number of Cobb angles

    X-rays were used to check the number of Cobb angles before and 4 months after the intervention to observe the improvement of scoliosis

    4 months before the intervention and 4 months after the intervention

  • Accuracy of new screening modalities

    The new screening method "general examination + forward flexion test + scoliosis measuring instrument" was used for examination, and the data results before and 4 months after intervention were compared with the X-ray examination results to verify its accuracy.

    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

    Depression status was rated using the Hamilton Depression Rating Scale

    4 months before and after the intervention, 4 months after the end of the intervention, and 8 months after the end of the intervention

Study Arms (2)

control

NO INTERVENTION

Conventional treatment

intervention

EXPERIMENTAL

Using paradigms based on transfer learning and semi-supervised learning, using multiple learning methods, transformer image classification algorithms and other mathematical methods, an early warning model and stepped treatment model for adolescent scoliosis were developed and verified, and a cost-effectiveness analysis was conducted at the same time.

Procedure: Conventional treatmentBehavioral: intervention treatment

Interventions

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 stimulation therapy

intervention

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

intervention

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 311000, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Xinyun Dr Li, doctor

    hangzhou medical colleage

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyun Dr LI, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations