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

NCT06648005 | Completed DMC

• 1 other identifier: 2022-K-380-01
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spinal manipulative therapye; brace; adolescent idiopathic scoliosis; moderate-grade; severe-grade; spinal deformity; quality of life

Outcome Measures

Primary Outcomes (1)

• curve reduction

  the curve reduction of 6° or more (treatment success) or curve reduction of less than 6° seen on pretherapy and post-treatment posteroanterior standing radiographs compared with the inclusion radiograph (treatment failure) . Radiographic measurements were conducted through radiographic images in the Digital Imaging and Communications in Medicine image format using the picture archiving and communication system, version 23.1 clinical imaging tool (Sectra PACS).

  Assessments were performed at baseline and after 3, 6, 12 months of treatment for each patient

Secondary Outcomes (3)

• Cobb angle

  at baseline and after 12-month of treatment

• ATR

  The ATR was collected at baseline and after 3, 6, 12month of treatment

• The Scoliosis Research Society-22 (SRS-22) questionnaire

  This questionnaire was assessed at subject enrollment and after 6, 12month of treatment

Study Arms (2)

SMTB group

EXPERIMENTAL

subjects in SMTB group and Brace group were all prescribed a brace with reference to the 2016 SOSORT guidelines and received preliminary assessment for brace design and fabrication at their first visit . 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. 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.

Procedure: the spinal manipulative therapy combined brace

Brace group

ACTIVE COMPARATOR

Upon enrollment, subjects in SMTB group and Brace group were all prescribed a brace with reference to the 2016 SOSORT guidelines and received preliminary assessment for brace design and fabrication at their first visit. 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.

Other: brace

Interventions

the spinal manipulative therapy combined brace PROCEDURE

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.

SMTB group

brace OTHER

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.

Brace group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Primary curve magnitude 20°-60° Cobb angle
• Signing informed consent and cooperating with treatment and follow-ups

You may not qualify if:

• The subjects with neuromuscular, rheumatic, cardiovascular, pulmonary, congenital spine-related disorders
• Psychiatric problems
• A history of spinal surgery

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

• Liu C, Wu YQ, Wang KQ, Wen Y, Li QS, Chen XM, Tang D, Du HG, Chen S. Spinal Manipulative Therapy for Moderate-to-Severe Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Chin J Integr Med. 2025 Dec 22. doi: 10.1007/s11655-025-4228-8. Online ahead of print.

  PMID: 41428026 DERIVED

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: July 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)