Actively Recruiting
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
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2025-03-12
128
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects and biomechanical impacts of different trigger modes of lever positioning manipulation (LPM) for treating lumbar disc herniation (LDH). This study aims to clarify the clinical efficacy of LPM, analyze the mechanical and spatial motion characteristics of its two trigger modes, and explore how these modes influence the stress-strain and flow-solid coupling effects on the lumbar intervertebral discs, particularly at the L4/5 segment. The investigation also uses 3D finite element technology combined with dynamic capture and mechanical sensing systems to better understand these effects. Participants include 64 LDH patients and 64 healthy volunteers divided into four groups: two patient groups receiving either unilateral or bilateral LPM or sham manipulation, and two healthy volunteer groups receiving unilateral or bilateral LPM. Treatments are administered every two days for a total of six sessions over two weeks. During manipulation, mechanical and kinematic data are collected using sensing gloves and motion capture systems. Additionally, a virtual simulation model is built from imaging data to analyze biomechanical loading and stress on the intervertebral discs under different LPM modes. Participants will complete clinical questionnaires such as the Visual Analog Scale (VAS) and Japanese Orthopaedic Association (JOA) scoring system to assess pain and function. Mechanical parameters and motion characteristics are recorded during manipulation sessions. Researchers will use these data alongside imaging and individual patient features to study correlations. The primary outcome is the overall clinical efficacy after two weeks. Secondary outcomes include pain and functional scores, as well as detailed mechanical and kinematic measurements during treatment.
CONDITIONS
Brief Title
A Biomechanical Study of the Lumbar Intervertebral Disc by Lever Positioning Manipulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 20 to 60 with no history of lumbar spine disease and no lumbar pain or diagnosis
- Patients aged 20 to 60 diagnosed with L4-L5 lumbar disc herniation by CT or MRI
- Stable vital signs with no serious systemic diseases or complications
- Willing to participate and accept manipulation treatment
- Signed informed consent form
You will not qualify if you...
- Lumbar vertebrae fracture or dislocation
- Lumbar spine or soft tissue tumor or tuberculosis
- Lumbar spine fusion, paravertebral bone bridges, or severe osteoporosis
- History of lumbar spine surgery or serious lumbar trauma
- Lumbar skin inflammation, skin breaks, or other skin conditions
- Serious diseases of heart, liver, kidney, or blood systems; psychiatric illness
- Extreme frailty or pregnancy
- Participation in other manipulative therapies that may interfere with this study
- Intolerable adverse reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive lever positioning manipulation or sham manipulation. The treatment involves manual massage and manipulation of the lumbar region to address lumbar disc herniation or for healthy volunteer assessment.
3 treatment visits during 1 week with additional assessments
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
L
Longhao Chen, Principal Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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