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
Adolescent idiopathic scoliosis (AIS)
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/computer-generated random number method to one of the following groups, with approximately 32 participants in each group. Outcome data are collected by personnel who do not participate in patient treatment. Group 1: Conventional tuina control group. Participants receive conventional tuina once weekly for 12 weeks. The treatment is performed with the participant in the prone position and includes rolling and kneading along both sides of the spine and the Bladder meridian, focused treatment at the curved spinal segment, pressing and kneading at related acupoints such as Xinshu, Feishu, Ganshu, Shenshu and Dachangshu, thumb muscle-relaxing techniques to the erector spinae, spinal pressing and oblique-pulling manipulation, followed by rolling and kneading along the paraspinal region. Group 2: Balance-restoring bone-setting therapy group. Participants receive balance-restoring bone-setting therapy combined with tuina once weekly for 12 weeks. With the participant in the prone position, the practitioner palpates along the Du meridian, Jiaji points and Bladder meridian on both sides of the spine to identify abnormal tender, tense or nodular points. These points are treated using pressing, plucking-kneading and one-finger Zen manipulation for approximately 10 minutes. Region-specific low-force bone-setting techniques are selected according to the affected spinal region, including head-lifting correction for cervical involvement, prone thoracic impulse correction for thoracic involvement and Long's traction-based lumbar bone-setting technique for lumbar involvement. Group 3: Combined therapy group. Participants receive the same balance-restoring bone-setting therapy as Group 2 and additionally wear an individualized modified airbag Cheneau orthosis. The orthosis consists of a Chenea
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
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