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Effect of Spinal Manipulative Therapy Combined with Brace in Moderate-severe Grade Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial

NCT06648005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-10-18

No results posted yet for this study

Summary

Objective: To determine whether spinal manipulative therapy combined with brace is superior to a control of brace alone in improving spinal deformity and quality of life of moderate-severe grade AIS.

Design: It is a prospective randomized controlled study. Patients who met the inclusion criteria were randomly assigned to either the spinal manipulative therapy combined brace group (SMTB) or the Brace group. All participants were prescribed with a GBW brace and the spinal manipulative regimen was provided to the subjects in the SMBT group. Cobb angle, angle of trunk rotation (ATR), quality of life (SRS-22), progression rates and surgical rates of the subjects were measured at baseline to the 12-month follow-up.

Conditions

  • Adolescent Idiopathic Scoliosis
  • Brace
  • Spinal Manipulative Therapy

Interventions

PROCEDURE

the spinal manipulative therapy combined brace

Besides bracing, the SMTB group was treated with spinal manipulative therapy. If discomfort occurs, we will stop the treatment immediately. Spinal manipulation is performed twice a week. Two doctors with 10 years of clinical experience will perform all examinations and manipulations. Intensive training was given to the physiotherapists in spinal manipulation. The doctors took the medical history of all participants and performed a clinical examination.

OTHER

brace

Subjects were requested to wear orthosis 23 hrs/d and 1 hr for personal hygiene and exercise activities. The subjects were treated for 12 months. In addition, interview for compliance was launched when the subjects came to the scoliosis clinic for follow-up visits.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-30
Completion
2024-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06648005 on ClinicalTrials.gov