A study of a modified brace and manual therapy for teenagers with sideways curvature of the spine
| ISRCTN | ISRCTN24501159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24501159 |
| Zhejiang Provincial Traditional Chinese Medicine Science and Technology Program project number | 2025ZL410 |
| Sponsor | Hangzhou Hospital of Traditional Chinese Medicine |
| Funders | Zhejiang Provincial Traditional Chinese Medicine Science and Technology Program, Hangzhou Hospital of Traditional Chinese Medicine |
- Submission date
- 25/05/2026
- Registration date
- 27/05/2026
- Last edited
- 26/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Adolescent idiopathic scoliosis is a sideways curvature of the spine that occurs during growth. It can affect posture, appearance, comfort, daily activity and quality of life. Bracing and manual therapy are used as conservative treatments for adolescents who do not need surgery, but long-term brace wearing can be uncomfortable and some patients find it difficult to continue. This study aims to find out whether a modified airbag Cheneau brace combined with balance-restoring bone-setting therapy can improve spinal curvature, posture and quality of life in teenagers with adolescent idiopathic scoliosis.
Who can participate?
Teenagers aged 10 to 18 years with adolescent idiopathic scoliosis who are suitable for conservative treatment, meet the study criteria, and whose legal guardian or representative provides written informed consent.
What does the study involve?
Participants are randomly assigned to one of three groups. One group receives conventional Chinese massage technique, tuina. A second group receives balance-restoring bone-setting therapy combined with tuina. A third group receives the same balance-restoring bone-setting therapy and also wears a modified airbag Cheneau brace. Treatment lasts for 12 weeks. The brace group has a short adaptation period and is then asked to wear the brace for most of the day, except during treatment, personal hygiene and exercise. Participants have spinal imaging, posture assessment and questionnaires before and after treatment, and are followed for 1 month after the treatment course.
What are the possible benefits and risks of participating?
Possible benefits include improvement in spinal alignment, posture, symptoms, comfort and quality of life. These benefits cannot be guaranteed. Possible risks include temporary soreness after manual therapy, local discomfort, skin redness or pressure discomfort from brace wearing, and inconvenience from repeated follow-up and imaging. The study team monitors participants and adjusts treatment if discomfort or adverse events occur.
Where is the study run from?
The study is run at Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
When is the study starting and how long is it expected to run for?
The project period is from January 2025 to December 2027. Participant recruitment is planned from July 2025 to December 2026, with treatment lasting 12 weeks and follow-up for 1 month after the treatment course.
Who is funding the study?
The study is supported by the Zhejiang Provincial Traditional Chinese Medicine Science and Technology Program and institutional matching funds from Hangzhou Hospital of Traditional Chinese Medicine.
Who is the main contact?
Yan Chen, Hangzhou Hospital of Traditional Chinese Medicine, chenyan000fox@163.com.
Contact information
Public, Scientific, Principal investigator
No. 453 Tiyuchang Road, Xihu District
Hangzhou
310007
China
 ORCID ID |
0009-0009-6931-9582 |
|---|---|
| Phone | +86 571 85827896 |
| 87406360@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Participant information sheet | 49588_Informed Consent Form [Chinese].pdf |
| Scientific title | 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 |
| Study acronym | PINGMI-AIS |
| Study objectives | 1. To evaluate whether a modified airbag Cheneau orthosis combined with balance-restoring bone-setting therapy improves spinal curvature in adolescents with idiopathic scoliosis compared with balance-restoring bone-setting therapy alone and conventional tuina. 2. To assess the effects of the combined treatment on posture, health-related quality of life, treatment satisfaction and clinical effectiveness indicators. 3. To assess the safety and feasibility of applying a Pingmi theory-based integrated conservative treatment pathway for adolescent idiopathic scoliosis. |
| Ethics approval(s) |
Approved 30/06/2025, Scientific Research Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine (No. 453 Tiyuchang Road, Xihu District, Hangzhou, Hangzhou, China; +86 571 85827896; 2057874175@qq.com), ref: 2025KLL168 |
| Health condition(s) or problem(s) studied | Adolescent idiopathic scoliosis (AIS) |
| Intervention | 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 Cheneau-type brace and adjustable airbag components. The brace is customized according to each participant's spinal curvature model. During the adaptation period in the first 5 days, participants wear the brace for at least 4 hours per day. After the adaptation period, participants are instructed to wear the brace for approximately 23 hours per day, removing it only for treatment, personal hygiene and exercise. Airbag inflation is adjusted according to Cobb angle and clinical assessment. Participants are instructed to perform deep-breathing pulmonary exercises. All groups receive study-related communication, rehabilitation education, guidance on posture, home exercise, diet and daily activities, follow-up reminders, imaging review arrangements and safety monitoring. Participants are followed during the 12-week treatment period and for 1 month after completion of the treatment course. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modified airbag Cheneau orthosis |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 96 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Tuina Department / Orthopedics Department, No. 453 Tiyuchang Road, Xihu District
310007
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 26/05/2026 | No | Yes |
Additional files
- 49588_Informed Consent Form [Chinese].pdf
- Participant information sheet
Editorial Notes
26/05/2026: Study’s existence confirmed by the Scientific Research Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine, China.
