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A study of a modified brace and manual therapy for teenagers with sideways curvature of the spine

A single-centre randomized parallel-group clinical study of a modified airbag Cheneau orthosis combined with balance-restoring bone-setting therapy compared with balance-restoring bone-setting therapy and conventional tuina for adolescent idiopathic scoliosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24501159
Enrollment
96
Registered
2026-05-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent idiopathic scoliosis (AIS) Musculoskeletal Diseases

Interventions

This is a single-centre, randomized, three-arm, parallel-group clinical study. Approximately 96 adolescents with adolescent idiopathic scoliosis are randomized in a 1:1:1 ratio using a digital/compute

Sponsors

Hangzhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Adolescents aged 10 to 18 years 2. Diagnosis of adolescent idiopathic scoliosis 3. Cobb angle less than 40 degrees and considered suitable for conservative treatment 4. Outpatients or inpatients treated at Hangzhou Hospital of Traditional Chinese Medicine who meet the study diagnostic, inclusion and exclusion criteria 5. Able to complete the planned 12-week treatment and follow-up assessments 6. The participant and his/her legal guardian or representative provide written informed consent according to the approved consent process

Exclusion criteria

Exclusion criteria: 1. Scoliosis requiring surgical treatment, including Cobb angle greater than 40 degrees, progressive worsening with clear surgical indication, obvious back pain requiring surgical evaluation, or neurological compression symptoms 2. Congenital, neuromuscular, syndromic, degenerative or other non-idiopathic scoliosis 3. Previous spinal surgery or other treatment that, in the investigator's judgment, would interfere with evaluation of the study interventions 4. Severe cardiopulmonary, neurological, infectious, metabolic bone, tumour-related or other systemic disease that makes participation unsafe 5. Contraindication to tuina, bone-setting manipulation, brace wearing or radiographic follow-up 6. Skin ulceration, severe skin disease or local condition preventing safe brace wearing 7. Inability to complete study treatment or follow-up assessments 8. Refusal of informed consent by the participant or legal guardian/representative

Countries

China

Contacts

Public ContactYan Chen
87406360@qq.com+86 571 85827896

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026