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A Biomechanical Study of the Lumbar Intervertebral Disc by Lever Positioning Manipulation

RecruitingNAAges 20 Years - 60 YearsAllThe Third Affiliated hospital of Zhejiang Chinese…
NCT06872918 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 investig

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📋 Eligibility rules (as published)
Inclusion Criteria: Healthy volunteers: 1. Healthy subjects with no history of lumbar spine disease, aged 20 to 60. 2. No obvious lumbar spine pain or previous diagnosis of lumbar spine-related disease. 3. Willing to participate in the study and have signed an informed consent form. Patients: 1. Aged 20 to 60 years. 2. Diagnosed with L4-L5 lumbar disc herniation by CT or MRI. 3. Stable vital signs, no serious systemic diseases, and no complications. 4. Willing to accept manipulation as a test subject. Exclusion Criteria: 1. Lumbar vertebrae fracture or dislocation. 2. Lumbar spine or lumbar soft tissue tumor, tuberculosis. 3. Lumbar spine fusion, paravertebral bone bridges, or severe osteoporosis. 4. History of lumbar spine surgery. 5. History of serious lumbar trauma. 6. Lumbar skin inflammation, skin breaks, or other skin conditions. 7. Serious primary diseases of the cardiac, hepatic, renal, or hematopoietic systems; psychiatric patients. 8. Extreme frailty or pregnancy. 9. Participation in other manipulative therapies that may interfere with the study. 10. Intolerable adverse reactions.
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What it tests

  • 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
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Where

1 site
The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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