ScoliosisNCT07325045
Biomechanical Study of Lever Positioning Manipulation on Scoliosis
A study testing Lever positioning manipulation in people with Scoliosis, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Research background Scoliosis is a common three-dimensional spinal deformity, especially in adolescents. In severe cases, it can lead to thoracic deformation and cardiopulmonary dysfunction. Read more about this study
- Who is it for?
- Ages 10 to 45 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Lever positioning manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 and 45 years, stable vital signs, no severe diseases in other systems;
- Diagnosed with scoliosis via standard anterior-posterior and lateral spinal radiographs, with a Cobb angle of 10° < θ <= 45°, and no severe complications;
- No history of spinal surgery;
- Voluntarily willing to participate in this study as a subject to undergo LPM procedures, and signing the informed consent form by themselves or their guardian. Note: Only patients meeting all of the above four criteria can be included in this study.
Who cannot join
- Individuals with severe osteoporosis, spinal fractures, tumors, infections, or lesions within the spinal canal;
- Those with related complications, such as cardiopulmonary insufficiency (NYHA class >= II) or severe neurological disorders;
- Those with compression fractures or spinal cord injuries;
- Individuals with cognitive impairment or mental disorders who cannot cooperate with biomechanical testing;
- Those with a history of spinal surgery;
- Those with severe skin lesions or dermatological diseases at the operation site;
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- Women who are menstruating, pregnant, planning pregnancy, or in the postpartum period;
- Those with other conditions that may reduce the likelihood of completing the procedure, such as a fear of manual therapy;
- Individuals with unclear surface markers, affecting motion capture accuracy (e.g., BMI >= 35 kg/m^2).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, Hangzhou, 310005
Yv Tian, 17683721740, tianyv2024@163.com
About this study
Official title: Biomechanical Parameter Quantification and Finite Element Simulation of Lever Positioning Manipulation in Patients With Thoracolumbar Scoliosis
Research background Scoliosis is a common three-dimensional spinal deformity, especially in adolescents. In severe cases, it can lead to thoracic deformation and cardiopulmonary dysfunction. At present, clinical treatment is mainly based on Cobb angle to take observation, brace or surgical intervention, but there are problems such as poor compliance and large trauma. As a non-invasive massage therapy, leverage positioning manipulation has shown orthopedic effects in clinical practice, but its biomechanical mechanism has not been systematically quantified, which restricts its standardization and promotion.
Purpose of the study The purpose of this study is to quantify the mechanical and kinematic parameters of lever positioning manipulation in the treatment of scoliosis through biomechanical testing and finite element simulation technology, to construct an individualized finite element model, to analyze the stress and strain distribution of each structure of the spine under the intervention of manipulation, to reveal its biomechanical mechanism, and to provide scientific basis for the standardization of manipulation and the optimization of curative effect.
Read more
Research contents and methods The study is divided into two parts : In the first part, 30 patients with scoliosis were recruited. Through the integrated mechanical sensor and motion capture system, the mechanical parameters ( such as preload force, maximum pull force ) and kinematic parameters ( such as angle, angular velocity ) during the manipulation were recorded in real time. In the second part, based on the CT data of patients, the three-dimensional finite element model of T10-L2 segment was constructed by using Mimics, Geomagic, SolidWorks and ANSYS software to simulate the loading process of manipulation and analyze the stress and strain response of vertebral body, intervertebral disc and ligament complex under the action of manipulation.
Expected results and significance This study will systematically quantify the biomechanical characteristics of lever positioning manipulation for the first time, and clarify its mechanism of action in the treatment of thoracolumbar scoliosis. Through the finite element simulation, the stress distribution is visualized, which provides data support for the precision and individualization of manipulation, promotes the transformation of massage manipulation from ' experience dependence ' to ' quantitative science ', and lays a theoretical foundation for the development of intelligent orthopedic equipment in the future.
Ethics and quality control The study has passed the ethical review, and all participants will sign the informed consent. The manipulation was performed by the same experienced physician, and the data collection and analysis process was strictly controlled to ensure that the results were true and reliable.
- Conditions
- Scoliosis
- Being tested
- Lever positioning manipulation
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lever positioning manipulationProcedure or surgery
1 The patient took the prone position, exposed the waist and back, relaxed the whole body, and straightened the lower limbs. 2 The surgeon determined the top vertebra of the scoliosis according to the whole spine X-ray film, and used the olecranon of the elbow as the force fulcrum to accurately press the transverse process or spinous process on the convex side of the top vertebra, and the assistant fixed the shoulder of the patient. 3 The patient was asked to open his mouth and exhale, and the operator lifted the patient 's lower limbs on the other hand. Through the force arm conduction of the lower limbs-pelvis-spine, the lower limbs were lifted obliquely above the convex side to form a force arm lever. 4 When pulling to the resistance point, the surgeon pulled quickly with inch force. After the operation, the patient was allowed to rest in a prone position for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lever positioning manipulation group | Experimental | Not described Receives: Procedure: Lever positioning manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
elbow pulling the maximum force：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
The operator wears mechanical measurement gloves and elbow sleeves to perform manual operation on the recipient. The mechanical parameters were collected by a pressure sensor, and the unit of measurement was Force ( Newton, N ). The average or peak value of each parameter was reported.
Measured: 2 weeks
Secondary outcomes (11)
maximum force of both hands pulling：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
The operator wears mechanical measurement gloves and elbow sleeves to perform manual operation on the recipient. The mechanical parameters were collected by a pressure sensor, and the unit of measurement was Force ( Newton, N ). The average or peak value of each parameter was reported.
Measured: 2 weeks
lateral flexion angle： Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
The operator performs manual operation on the subject, and collects the kinematic parameters of the manual operation through the three-dimensional motion capture system equipment, and the measurement unit is : degree.
Measured: 2 weeks
rotation angle： Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
The operator performs manual operation on the subject, and collects the kinematic parameters of the manual operation through the three-dimensional motion capture system equipment, and the measurement unit is : degree.
Measured: 2 weeks
pulling time：Through the three-dimensional motion capture system, the time of the manipulation process is recorded.
The operator performs the manual operation on the subject, collects the kinematic parameters of the manual operation through the three-dimensional motion capture system equipment, and records the manual operation time at the same time. The measurement unit is seconds ( S ).
Measured: 2 weeks
pulling angular acceleration：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
The operator performs the manual operation on the subject, collects the kinematic parameters of the manual operation through the three-dimensional motion capture system equipment, and records the manual operation time and angular velocity. The acceleration is calculated and the average and maximum values are recorded.
Measured: 2 weeks
extension angle：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
The operator performs manipulation on the subject, collects the kinematics parameters of the manipulation through the three-dimensional motion capture system equipment, and records the angle.
Measured: 2 weeks
preloading force of both hands：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
The operator wears mechanical measurement gloves and elbow sleeves to perform manual operation on the recipient. The mechanical parameters were collected by a pressure sensor, and the unit of measurement was Force ( Newton, N ). The average or peak value of each parameter was reported.
Measured: 2 weeks
Elbow preload force：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
The operator wears mechanical measurement gloves and elbow sleeves to perform manual operation on the recipient. The mechanical parameters were collected by a pressure sensor, and the unit of measurement was Force ( Newton, N ). The average or peak value of each parameter was reported.
Measured: 2 weeks
average pulling angular velocity：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
The operator performs manipulation on the subject. The kinematics parameters of the manipulation are collected by the three-dimensional motion capture system equipment, the angle change and time are recorded, the angular velocity is calculated, and the average value and the highest value are calculated.
Measured: 2 weeks
The stress of each structure：Through the analysis of finite element software, the stress of the spine under the intervention of manipulation was simulated.
The kinematics and mechanics data of the manipulation operation measured above were statistically analyzed. These data were input into the three-dimensional finite element model of the spine to simulate the manipulation. Through the finite element software analysis, the stress change cloud map and data of the spine were obtained, including the average value and the maximum and minimum values.
Measured: 2 weeks
Strain of each structure：Through the analysis of finite element software, the strain of the spine under the intervention of manipulation was simulated.
The kinematics and mechanics data of the manipulation of the previous measurement were statistically analyzed. The data were input into the three-dimensional finite element model of the spine to simulate the manipulation. Through the analysis of the finite element software, the strain cloud map and displacement data of the spine were obtained, including the average value and the maximum and minimum values.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Tian Yv, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325045
- Sponsor's protocol ID
- ZSLL-KY-2025-101-01
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Parameter Quantification and Finite Element Simulation of Lever Positioning Manipulation in Patients With Thoracolumbar Scoliosis
- ClinicalTrials.gov ID
- NCT07325045
- Acronym / sponsor ID
- ZSLL-KY-2025-101-01
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Chinese Medical University
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research background Scoliosis is a common three-dimensional spinal deformity, especially in adolescents. In severe cases, it can lead to thoracic deformation and cardiopulmonary dysfunction. At present, clinical treatment is mainly based on Cobb angle to take observation, brace or surgical intervention, but there are problems such as poor compliance and large trauma. As a non-invasive massage therapy, leverage positioning manipulation has shown orthopedic effects in clinical practice, but its biomechanical mechanism has not been systematically quantified, which restricts its standardization and promotion.
Purpose of the study The purpose of this study is to quantify the mechanical and kinematic parameters of lever positioning manipulation in the treatment of scoliosis through biomechanical testing and finite element simulation technology, to construct an individualized finite element model, to analyze the stress and strain distribution of each structure of the spine under the intervention of manipulation, to reveal its biomechanical mechanism, and to provide scientific basis for the standardization of manipulation and the optimization of curative effect.
Research contents and methods The study is divided into two parts : In the first part, 30 patients with scoliosis were recruited. Through the integrated mechanical sensor and motion capture system, the mechanical parameters ( such as preload force, maximum pull force ) and kinematic parameters ( such as angle, angular velocity ) during the manipulation were recorded in real time. In the second part, based on the CT data of patients, the three-dimensional finite element model of T10-L2 segment was constructed by using Mimics, Geomagic, SolidWorks and ANSYS software to simulate the loading process of manipulation and analyze the stress and strain response of vertebral body, intervertebral disc and ligament complex under the action of manipulation.
Expected results and significance This study will systematically quantify the biomechanical characteristics of lever positioning manipulation for the first time, and clarify its mechanism of action in the treatment of thoracolumbar scoliosis. Through the finite element simulation, the stress distribution is visualized, which provides data support for the precision and individualization of manipulation, promotes the transformation of massage manipulation from ' experience dependence ' to ' quantitative science ', and lays a theoretical foundation for the development of intelligent orthopedic equipment in the future.
Ethics and quality control The study has passed the ethical review, and all participants will sign the informed consent. The manipulation was performed by the same experienced physician, and the data collection and analysis process was strictly controlled to ensure that the results were true and reliable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lever positioning manipulation group | Experimental | Procedure: Lever positioning manipulation |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 10 and 45 years, stable vital signs, no severe diseases in other systems;
- Diagnosed with scoliosis via standard anterior-posterior and lateral spinal radiographs, with a Cobb angle of 10° < θ <= 45°, and no severe complications;
- No history of spinal surgery;
- Voluntarily willing to participate in this study as a subject to undergo LPM procedures, and signing the informed consent form by themselves or their guardian. Note: Only patients meeting all of the above four criteria can be included in this study.
Key exclusion criteria (9 listed)
- Individuals with severe osteoporosis, spinal fractures, tumors, infections, or lesions within the spinal canal;
- Those with related complications, such as cardiopulmonary insufficiency (NYHA class >= II) or severe neurological disorders;
- Those with compression fractures or spinal cord injuries;
- Individuals with cognitive impairment or mental disorders who cannot cooperate with biomechanical testing;
- Those with a history of spinal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lever positioning manipulation1 The patient took the prone position, exposed the waist and back, relaxed the whole body, and straightened the lower limbs. 2 The surgeon determined the top vertebra of the scoliosis according to the whole spine X-ray film, and used the olecranon of the elbow as the force fulcrum to accurately press the transverse process or spinous process on the convex side of the top vertebra, and the assistant fixed the shoulder of the patient. 3 The patient was asked to open his mouth and exhale, and the operator lifted the patient 's lower limbs on the other hand. Through the force arm conduction of the lower limbs-pelvis-spine, the lower limbs were lifted obliquely above the convex side to form a force arm lever. 4 When pulling to the resistance point, the surgeon pulled quickly with inch force. After the operation, the patient was allowed to rest in a prone position for 10 minutes. | Procedure or surgery | Lever positioning manipulation group |
Primary outcome
elbow pulling the maximum force：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
Time frame: 2 weeks
The operator wears mechanical measurement gloves and elbow sleeves to perform manual operation on the recipient. The mechanical parameters were collected by a pressure sensor, and the unit of measurement was Force ( Newton, N ). The average or peak value of each parameter was reported.
11 secondary outcomes
maximum force of both hands pulling：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
Time frame: 2 weeks
lateral flexion angle： Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
Time frame: 2 weeks
rotation angle： Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
Time frame: 2 weeks
pulling time：Through the three-dimensional motion capture system, the time of the manipulation process is recorded.
Time frame: 2 weeks
pulling angular acceleration：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
Time frame: 2 weeks
extension angle：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
Time frame: 2 weeks
preloading force of both hands：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
Time frame: 2 weeks
Elbow preload force：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected.
Time frame: 2 weeks
average pulling angular velocity：Through the three-dimensional motion capture system, the kinematic parameters of spinal activity during manipulation were collected.
Time frame: 2 weeks
The stress of each structure：Through the analysis of finite element software, the stress of the spine under the intervention of manipulation was simulated.
Time frame: 2 weeks
Strain of each structure：Through the analysis of finite element software, the strain of the spine under the intervention of manipulation was simulated.
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lever positioning manipulation in people with Scoliosis, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yv Tian (17683721740, tianyv2024@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elbow pulling the maximum force：Through the mechanical gloves and elbow sleeves, the mechanical parameters in the process of manual operation were collected. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.