Biomechanical evaluation of lumbar disc herniation treatment using lever positioning manipulation

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

This study is testing different ways of using a special manipulation technique to see if it can help people with lumbar disc herniation feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06872918 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of different trigger modes of lever positioning manipulation (LPM) for treating lumbar disc herniation (LDH). It employs advanced 3D finite element technology and dynamic capture systems to analyze the biomechanical effects of LPM on patients with LDH. The study aims to clarify the clinical impact of LPM and to summarize the mechanical characteristics associated with different triggering modes. Additionally, it seeks to correlate LPM operation characteristics with individual patient traits and imaging parameters.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 20 to 60 diagnosed with L4-L5 lumbar disc herniation confirmed by imaging.

Not a fit: Patients with a history of serious lumbar conditions, fractures, or systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel and effective treatment option for patients suffering from lumbar disc herniation.

How similar studies have performed: While this approach is innovative, it is unclear if similar studies have shown success, as this methodology appears to be relatively novel.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Longhao Chen, Principal Investigator

Conditions Lumbar Disc Herniation