Lumbar Disc HerniationNCT06872918
A Biomechanical Study of the Lumbar Intervertebral Disc by Lever Positioning Manipulation
A study testing Lever positioning manipulation, Cluster of pseudo-manipulators and Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation in people with Lumbar Disc Herniation, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Purpose of Study: The purpose of this clinical trial is the clinical efficacy of different trigger modes of lever positioning manipulation (LPM) for the treatment of lumbar disc herniation (LDH). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Lever positioning manipulation, Cluster of pseudo-manipulators and Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers:
- Healthy subjects with no history of lumbar spine disease, aged 20 to 60.
- No obvious lumbar spine pain or previous diagnosis of lumbar spine-related disease.
- Willing to participate in the study and have signed an informed consent form.
- Patients:
- Aged 20 to 60 years.
Show all 9Show fewer
- Diagnosed with L4-L5 lumbar disc herniation by CT or MRI.
- Stable vital signs, no serious systemic diseases, and no complications.
- Willing to accept manipulation as a test subject.
Who cannot join
- Lumbar vertebrae fracture or dislocation.
- Lumbar spine or lumbar soft tissue tumor, tuberculosis.
- Lumbar spine fusion, paravertebral bone bridges, or severe osteoporosis.
- History of lumbar spine surgery.
- History of serious lumbar trauma.
- Lumbar skin inflammation, skin breaks, or other skin conditions.
Show all 10Show fewer
- Serious primary diseases of the cardiac, hepatic, renal, or hematopoietic systems; psychiatric patients.
- Extreme frailty or pregnancy.
- Participation in other manipulative therapies that may interfere with the study.
- Intolerable adverse reactions.
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, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310005
About this study
Official title: Study on the Stress-Strain and Flow-Solid Coupling Effects on Lumbar Intervertebral Discs Under Transient Loading by Lever Positioning Manipulation with Different Triggering Modes
Purpose of Study:
The purpose of this clinical trial is the clinical efficacy of different trigger modes of lever positioning manipulation (LPM) for the treatment of lumbar disc herniation (LDH). At the same time, the investigators considered from the perspective of virtual simulation and applied 3D finite element technology combined with dynamic capture system and mechanical sensing system to comprehensively evaluate the characteristics of biomechanical effects of different triggering modes of LPM on LDH.
Read more
The main questions ansthe investigatorsred are:
(1) To clarify what is the clinical effect of LPM in treating lumbar disc herniation?(2) Summarize the spatial motion laws and mechanical characteristics of the two triggering modes of LPM. Analyze the correlation betthe investigatorsen the LPM operation characteristics and the individual characteristics of LDH patients as the investigatorsll as the imaging parameters, and clarify the differences betthe investigatorsen the two LPM two trigger modes.(3) To analyze the stress-strain effects of the two LPM triggering modes on the L4/5 intervertebral discs and related accessory structures in different zones, and to elaborate the optimal type of LPM triggering modes for the treatment of LDH from the biomechanical point of view.(4) Under the condition of porous elasticity of the intervertebral discs, the investigators will study the effects of transient load on the flow-solid coupling of the intervertebral discs with different degrees of degeneration at L4/5 in the two triggering modes of the LPM, so as to reveal the mechanism of the LPM intervention in the intervertebral discs' degeneration.
The main research includes the following four aspects:
(1) Clinical efficacy study and standardized data collection of LPM.This study plans to recruit 128 volunteers from the Third Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine will be recruited for the study. Sixty-four LDH patients and 64 healthy volunteers the investigatorsre planned to be included in this study. The LDH patients the investigatorsre divided into lever positioning manipulation group (group 1, n=32) sham manipulation group (group 2, n=32) using random number table method. In this group, unilateral wrenching mode was used for patients with paracentral LDH and bilateral wrenching mode was used for patients with central LDH. Manipulation was performed every two days, receiving a total of 6 sessions over 2 the investigatorseks. Healthy volunteers the investigatorsre similarly categorized into unilateral trigger mode group (group 3, n=32) bilateral trigger mode group (group 4, n=32) using random number table method. LPM treatments the investigatorsre administered every two days, receiving a total of 6 sessions over 2 the investigatorseks. Participants in both Group 1 and Group 2 the investigatorsre required to complete clinical questionnaire assessments, including the Visual Analog Scale (VAS) and the Japanese Orthopaedic Association (JOA) scoring system. During the LPM operation, the performer wore a mechanical sensing glove to collect the mechanical parameters of the maneuver, while a motion capture system was used to collect the kinematic parameters of the LPM, and the individual characteristics and imaging parameters of all the volunteers the investigatorsre collected, so as to analyze the correlation betthe investigatorsen the mechanical parameters, kinematic parameters, and the individual factors of the patients with LDH.(2) Virtual simulation model building and maneuver loading analysis.One standard volunteer was selected among 64 healthy volunteers, and the lumbar spine-pelvis imaging CT data the investigatorsre imported into Mimics software for geometric model extraction and preliminary processing. Geomagic and other software the investigatorsre utilized to construct the lumbar spine 3D finite element simulation model. And based on Abaqus CAE finite element simulation software, two kinds of wrenching mode maneuvers of LPM the investigatorsre simulated and loaded. The kinematic and mechanical parameters of the LPM the investigatorsre disassembled and loaded into each model to obtain the analytical models of manipulation in different trigger modes. The experimental results the investigatorsre obtained by calculating and analyzing the working conditions of LPM through Abaqus software. Observe the stress and strain on the intervertebral disc and ancillary structures under the action of LPM in different pulling modes.(3) Fluid-solid coupling effect of LPM on lumbar intervertebral disc under transient loads.Under the condition of considering the porous elasticity of the intervertebral disc, the coupled flow-stress simulation in Abaqus CAE was utilized to study the coupled flow-solid effect of the intervertebral disc, and then loaded to simulate the LPM manipulation, and observed the changes such as the stress displacement of the intervertebral disc under the manipulation.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Lever positioning manipulation, Cluster of pseudo-manipulators, Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation, Mechanics and kinematics data acquisition of bilateral wrenching patterns in lever positioning manipulation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lever positioning manipulationProcedure or surgery
The patient was placed in the prone position, and the doctor used one-finger Zen pushing, rolling, pressing and kneading, flicking and plucking methods in the patient's lumbar region and the affected side of the lower limb pain repeated massage treatment for 15min; the patient was placed in the prone open-mouth position, and the operator stood on the right side of his/her body, so that the whole body of the patient's muscles were relaxed. According to the type of herniation, the patient with paracentral lumbar disc herniation performed unilateral triggering mode, and the patient with central lumbar disc herniation performed bilateral triggering mode.
Cluster of pseudo-manipulatorsProcedure or surgery
Sham manipulation treatment was given. Recipients take the prone position, the medical practitioner with a finger Zen push method, rolling method, pressing and kneading method, flicking and plucking method in the patient's lumbar region and the affected side of the lower limbs of the pain in the repeated massage treatment for 15min; patients prone position, with traction rope fixed lumbar disc herniation side of the affected limb, so that the affected limb back to the maximum extent of the extension, and then release the traction rope, simulating the backward extension of the force of the lever positioning manipulation, the medical practitioner does not do any manipulation.
Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulationProcedure or surgery
During the unilateral trigger mode operation of the lever positioning manipulation, the operator wears a mechanics sensing glove to collect the mechanics parameters of the manipulation, including: hand preload force, hand trigger maximum force, elbow compression preload force, and elbow compression maximum force. At the same time, a motion capture system was used to collect the kinematic parameters of the lever positioning manipulation, including: loading backward extension angle, loading backward extension trigger angle, average trigger time, maximum speed, and maximum acceleration.
Mechanics and kinematics data acquisition of bilateral wrenching patterns in lever positioning manipulationProcedure or surgery
During the bilateral triggering mode operation of the lever positioning manipulation, the operator wore a mechanics sensing glove to collect the mechanics parameters of the manipulation, including: hand preload force, hand triggering maximum force, elbow pressing preload force, and elbow pressing maximum force. At the same time, a motion capture system was used to collect the kinematic parameters of the lever positioning manipulation, including: loading backward extension angle, loading backward extension trigger angle, average trigger time, maximum speed, and maximum acceleration.
| Study group | Role | What they receive |
|---|---|---|
| Lever positioning manipulation patient group | Experimental | Not described Receives: Procedure: Lever positioning manipulation |
| Sham manipulation patient group | Sham comparator | Not described Receives: Procedure: Cluster of pseudo-manipulators |
| Lever Positioning Manipulation Unilateral Trigger Mode Healthy Volunteer Groups | Experimental | Not described Receives: Procedure: Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation |
| Lever Positioning Manipulation Bilateral Trigger Patterns Healthy Volunteer Groups | Experimental | Not described Receives: Procedure: Mechanics and kinematics data acquisition of bilateral wrenching patterns in lever positioning manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall effective rate of clinical efficacy
The efficacy was evaluated according to the Criteria for Diagnosis and Efficacy of Traditional Chinese Medicine (TCM) Diseases and Evidence issued by the State Administration of Traditional Chinese Medicine (SATCM) of China in 1994. Total effective rate = (cured + apparent effect + effective) / total number of cases × 100 percent. The efficacy is categorized into the following four grades:cured、apparent effect 、effective、ineffective.
Units of Measure: percentage. Aggregation Method: Calculate the total effective rate.
Measured: 2 weeks
Secondary outcomes (7)
Pain Visual Analogue Scale (VAS)
Pain level was assessed using the VAS scale. The patient marks the level of pain on a 10 cm long line, with 0 indicating no pain and 10 indicating the worst pain. Higher scores indicate more severe pain.
Units of Measure: score (0-10). Aggregation Method: reports the mean or median score.
Measured: 2 weeks
JOA Score for Low Back Pain (Japanese Orthopaedic Association Score for Low Back Pain)
Patients were evaluated for signs, symptoms, and dysfunction using the JOA scoring system for low back pain. Scores range from 0 to 29, with higher scores indicating less severe low back pain symptoms and better functional recovery.
Units of Measure: score (0-29). Aggregation Method: reports the mean or median score.
Measured: 2 weeks
Mechanical parameters during manipulation of the maneuver
The operator wears a manipulative mechanics measurement glove and elbow sleeve and secures it, and performs the manipulation at the recipient's waist. Mechanical parameters were collected by means of pressure transducers, including: hand preload force, hand trigger maximum force, elbow compression preload force, and elbow compression maximum force.
Units of Measure: Force (Newton, N) Aggregation Method: reports the average or peak value for each parameter.
Measured: 1 week for 3 times
Kinematic parameters at the time of manipulation
The Marker points of the motion capture system were placed by the applicator and the patient, and after the motion capture system was calibrated successfully, the manipulation was performed at the waist of the patient. Measurement of kinematic parameters, including: loaded back extension angle, loaded back extension trigger angle.
Units of Measure:
- Angle (degrees, °) Aggregation Method: reports the average or peak value for each parameter.
Measured: 1 week for 3 times
Average trigger time at the time of manipulation
The Marker points of the motion capture system were placed by the applicator and the patient, and after the motion capture system was calibrated successfully, the manipulation was performed at the waist of the patient. Measurement of kinematic parameters, including: average trigger time.
Units of Measure:
-Time (sec, s) Aggregation Method: reports the average or peak value for each parameter.
Measured: 1 week for 3 times
Maximum speed at the time of manipulation
The Marker points of the motion capture system were placed by the applicator and the patient, and after the motion capture system was calibrated successfully, the manipulation was performed at the waist of the patient. Measurement of kinematic parameters, including: maximum speed.
Units of Measure:
-Velocity (deg/sec, °/s) Aggregation Method: reports the average or peak value for each parameter.
Measured: 1 week for 3 times
Maximum acceleration at the time of manipulation
The Marker points of the motion capture system were placed by the applicator and the patient, and after the motion capture system was calibrated successfully, the manipulation was performed at the waist of the patient. Measurement of kinematic parameters, including: maximum acceleration.
Units of Measure:
-Acceleration (deg/sec², °/s²) Aggregation Method: reports the average or peak value for each parameter.
Measured: 1 week for 3 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jan 2024
- 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 Lumbar Disc HerniationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Longhao Chen, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872918
- Sponsor's protocol ID
- ZSLL-KY-2024-080-01
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Stress-Strain and Flow-Solid Coupling Effects on Lumbar Intervertebral Discs Under Transient Loading by Lever Positioning Manipulation with Different Triggering Modes
- ClinicalTrials.gov ID
- NCT06872918
- Acronym / sponsor ID
- ZSLL-KY-2024-080-01
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (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.
Purpose of Study:
The purpose of this clinical trial is the clinical efficacy of different trigger modes of lever positioning manipulation (LPM) for the treatment of lumbar disc herniation (LDH). At the same time, the investigators considered from the perspective of virtual simulation and applied 3D finite element technology combined with dynamic capture system and mechanical sensing system to comprehensively evaluate the characteristics of biomechanical effects of different triggering modes of LPM on LDH.
The main questions ansthe investigatorsred are:
(1) To clarify what is the clinical effect of LPM in treating lumbar disc herniation?(2) Summarize the spatial motion laws and mechanical characteristics of the two triggering modes of LPM. Analyze the correlation betthe investigatorsen the LPM operation characteristics and the individual characteristics of LDH patients as the investigatorsll as the imaging parameters, and clarify the differences betthe investigatorsen the two LPM two trigger modes.(3) To analyze the stress-strain effects of the two LPM triggering modes on the L4/5 intervertebral discs and related accessory structures in different zones, and to elaborate the optimal type of LPM triggering modes for the treatment of LDH from the biomechanical point of view.(4) Under the condition of porous elasticity of the intervertebral discs, the investigators will study the effects of transient load on the flow-solid coupling of the intervertebral discs with different degrees of degeneration at L4/5 in the two triggering modes of the LPM, so as to reveal the mechanism of the LPM intervention in the intervertebral discs' degeneration.
The main research includes the following four aspects:
(1) Clinical efficacy study and standardized data collection of LPM.This study plans to recruit 128 volunteers from the Third Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine will be recruited for the study. Sixty-four LDH patients and 64 healthy volunteers the investigatorsre planned to be included in this study. The LDH patients the investigatorsre divided into lever positioning manipulation group (group 1, n=32) sham manipulation group (group 2, n=32) using random number table method. In this group, unilateral wrenching mode was used for patients with paracentral LDH and bilateral wrenching mode was used for patients with central LDH. Manipulation was performed every two days, receiving a total of 6 sessions over 2 the investigatorseks. Healthy volunteers the investigatorsre similarly categorized into unilateral trigger mode group (group 3, n=32) bilateral trigger mode group (group 4, n=32) using random number table method. LPM treatments the investigatorsre administered every two days, receiving a total of 6 sessions over 2 the investigatorseks. Participants in both Group 1 and Group 2 the investigatorsre required to complete clinical questionnaire assessments, including the Visual Analog Scale (VAS) and the Japanese Orthopaedic Association (JOA) scoring system. During the LPM operation, the performer wore a mechanical sensing glove to collect the mechanical parameters of the maneuver, while a motion capture system was used to collect the kinematic parameters of the LPM, and the individual characteristics and imaging parameters of all the volunteers the investigatorsre collected, so as to analyze the correlation betthe investigatorsen the mechanical parameters, kinematic parameters, and the individual factors of the patients with LDH.(2) Virtual simulation model building and maneuver loading analysis.One standard volunteer was selected among 64 healthy volunteers, and the lumbar spine-pelvis imaging CT data the investigatorsre imported into Mimics software for geometric model extraction and preliminary processing. Geomagic and other software the investigatorsre utilized to construct the lumbar spine 3D finite element simulation model. And based on Abaqus CAE finite element simulation software, two kinds of wrenching mode maneuvers of LPM the investigatorsre simulated and loaded. The kinematic and mechanical parameters of the LPM the investigatorsre disassembled and loaded into each model to obtain the analytical models of manipulation in different trigger modes. The experimental results the investigatorsre obtained by calculating and analyzing the working conditions of LPM through Abaqus software. Observe the stress and strain on the intervertebral disc and ancillary structures under the action of LPM in different pulling modes.(3) Fluid-solid coupling effect of LPM on lumbar intervertebral disc under transient loads.Under the condition of considering the porous elasticity of the intervertebral disc, the coupled flow-stress simulation in Abaqus CAE was utilized to study the coupled flow-solid effect of the intervertebral disc, and then loaded to simulate the LPM manipulation, and observed the changes such as the stress displacement of the intervertebral disc under the manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lever positioning manipulation patient group | Experimental | Procedure: Lever positioning manipulation |
| Sham manipulation patient group | Sham comparator | Procedure: Cluster of pseudo-manipulators |
| Lever Positioning Manipulation Unilateral Trigger Mode Healthy Volunteer Groups | Experimental | Procedure: Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation |
| Lever Positioning Manipulation Bilateral Trigger Patterns Healthy Volunteer Groups | Experimental | Procedure: Mechanics and kinematics data acquisition of bilateral wrenching patterns in lever positioning manipulation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subjects with no history of lumbar spine disease, aged 20 to 60.
- No obvious lumbar spine pain or previous diagnosis of lumbar spine-related disease.
- Willing to participate in the study and have signed an informed consent form.
- Aged 20 to 60 years.
- Diagnosed with L4-L5 lumbar disc herniation by CT or MRI.
Key exclusion criteria (10 listed)
- Lumbar vertebrae fracture or dislocation.
- Lumbar spine or lumbar soft tissue tumor, tuberculosis.
- Lumbar spine fusion, paravertebral bone bridges, or severe osteoporosis.
- History of lumbar spine surgery.
- History of serious lumbar trauma.
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 manipulationThe patient was placed in the prone position, and the doctor used one-finger Zen pushing, rolling, pressing and kneading, flicking and plucking methods in the patient's lumbar region and the affected side of the lower limb pain repeated massage treatment for 15min; the patient was placed in the prone open-mouth position, and the operator stood on the right side of his/her body, so that the whole body of the patient's muscles were relaxed. According to the type of herniation, the patient with paracentral lumbar disc herniation performed unilateral triggering mode, and the patient with central lumbar disc herniation performed bilateral triggering mode. | Procedure or surgery | Lever positioning manipulation patient group |
| Cluster of pseudo-manipulatorsSham manipulation treatment was given. Recipients take the prone position, the medical practitioner with a finger Zen push method, rolling method, pressing and kneading method, flicking and plucking method in the patient's lumbar region and the affected side of the lower limbs of the pain in the repeated massage treatment for 15min; patients prone position, with traction rope fixed lumbar disc herniation side of the affected limb, so that the affected limb back to the maximum extent of the extension, and then release the traction rope, simulating the backward extension of the force of the lever positioning manipulation, the medical practitioner does not do any manipulation. | Procedure or surgery | Sham manipulation patient group |
| Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulationDuring the unilateral trigger mode operation of the lever positioning manipulation, the operator wears a mechanics sensing glove to collect the mechanics parameters of the manipulation, including: hand preload force, hand trigger maximum force, elbow compression preload force, and elbow compression maximum force. At the same time, a motion capture system was used to collect the kinematic parameters of the lever positioning manipulation, including: loading backward extension angle, loading backward extension trigger angle, average trigger time, maximum speed, and maximum acceleration. | Procedure or surgery | Lever Positioning Manipulation Unilateral Trigger Mode Healthy Volunteer Groups |
| Mechanics and kinematics data acquisition of bilateral wrenching patterns in lever positioning manipulationDuring the bilateral triggering mode operation of the lever positioning manipulation, the operator wore a mechanics sensing glove to collect the mechanics parameters of the manipulation, including: hand preload force, hand triggering maximum force, elbow pressing preload force, and elbow pressing maximum force. At the same time, a motion capture system was used to collect the kinematic parameters of the lever positioning manipulation, including: loading backward extension angle, loading backward extension trigger angle, average trigger time, maximum speed, and maximum acceleration. | Procedure or surgery | Lever Positioning Manipulation Bilateral Trigger Patterns Healthy Volunteer Groups |
Primary outcome
Overall effective rate of clinical efficacy
Time frame: 2 weeks
The efficacy was evaluated according to the Criteria for Diagnosis and Efficacy of Traditional Chinese Medicine (TCM) Diseases and Evidence issued by the State Administration of Traditional Chinese Medicine (SATCM) of China in 1994. Total effective rate = (cured + apparent effect + effective) / total number of cases × 100 percent. The efficacy is categorized into the following four grades:cured、apparent effect 、effective、ineffective. Units of Measure: percentage. Aggregation Method: Calculate the total effective rate.
7 secondary outcomes
Pain Visual Analogue Scale (VAS)
Time frame: 2 weeks
JOA Score for Low Back Pain (Japanese Orthopaedic Association Score for Low Back Pain)
Time frame: 2 weeks
Mechanical parameters during manipulation of the maneuver
Time frame: 1 week for 3 times
Kinematic parameters at the time of manipulation
Time frame: 1 week for 3 times
Average trigger time at the time of manipulation
Time frame: 1 week for 3 times
Maximum speed at the time of manipulation
Time frame: 1 week for 3 times
Maximum acceleration at the time of manipulation
Time frame: 1 week for 3 times
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 12 Mar 2025.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
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, Cluster of pseudo-manipulators and Mechanics and kinematics data acquisition of unilateral wrenching patterns in lever positioning manipulation in people with Lumbar Disc Herniation, 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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. Some participants in this study may receive a placebo. 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 Longhao Chen, Principal Investigator (18878980512, 842904345@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall effective rate of clinical efficacy (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 12 Mar 2025.