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A Study on the Prognosis and Mechanism of Dynamic Orthopedic Manipulation Therapy for Massive Rupture Type Lumbar Disc Herniation Using Deep Learning Combined with the DIERS Fometric 3D Assessment System and MRI Radiomics

A Study on the Prognosis and Mechanism of Dynamic Orthopedic Manipulation Therapy for Massive Rupture Type Lumbar Disc Herniation Using Deep Learning Combined with the DIERS Fometric 3D Assessment System and MRI Radiomics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000462
Enrollment
Unknown
Registered
2026-03-05
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Ruptured Lumbar Disc Herniation

Interventions

Conventional treatment group:Bed rest + Wearing a waist brace + Acupuncture (needling: Ah Shi points, Dachangshu, Shenshu, etc.) + Oral Celecoxib/Eperisone (when pain is unbearable)
Dong Zheng Spinal Manipulation Group:Conventional treatment (bed rest + waist brace + acupuncture) + Dynamic Spinal Manipulation (Shaking Legs and Kneading Waist Method + Prone Traction, Shaking, and

Sponsors

Guangdong Second Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for lumbar disc herniation. 2. MRI shows imaging features consistent with giant/broken-type disc herniation (Giant type: The herniation rate HR of the responsible segment disc >50% or the herniated disc exceeds 50% of the sagittal diameter of the spinal canal; Broken type: On MRI sagittal views, the herniated material extends more than 5mm beyond the posterior margin of the vertebral body, with rough and irregular edges, and the black line at the contact site between the herniated material and the posterior margin of the vertebral body is interrupted). 3. Is able to actively cooperate and complete clinical observations. 4. Age between 18 and 65 years. 5. Voluntarily participates in this study, has signed the informed consent form, has complete imaging data, and has a follow-up period of more than 6 months. 6. If previously received other manual or conservative treatments, a washout period of more than 5 days has been completed.

Exclusion criteria

Exclusion criteria: 1. Clinical symptoms are extremely severe, requiring surgical treatment. 2. Coexisting severe primary diseases of the digestive system, cardiovascular system (such as hypertension or coronary artery disease), hematopoietic system, or mental disorders. 3. Pregnant or breastfeeding women. 4. Coexisting vertebral fractures, spinal cord tumors, or compression symptoms caused by factors other than lumbar disc herniation. 5. Poor compliance, unable to attend follow-up appointments at this hospital, unable to undergo MRI examinations, or incomplete preservation of imaging data.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale (VAS) for Pain Score;Japanese Orthopedic Association Low Back Pain Score;Oswestry Disability Index;Kyphotic angle VP-T12;Lordotic angle T12-DM;Trunk Sagittal Plane Inclination Angle;Trunk Sagittal Plane Tilt Distance;Trunk coronal plane inclination angle;Trunk coronal plane tilt distance;Rotation angle of the L1-L5 vertebra (arithmetic square root);Average offset of all vertebral bodies (the arithmetic square root of all vertebral offsets);Trunk Twist Angle;Pelvic Sagittal Plane Inclination Angle;axis deviation angle;Pelvic Coronal Plane Internal Inclination Angle;Pelvic Rotation Angle;Pelvic Torsion Angle;Protrusion segment disc height;Protrusion Size;Highlighted Segment;Is there any Modic change?;The Pfirrmann classification of the protruding segment.;

Secondary

MeasureTime frame
Recombinant HMGB1 protein;IL-1ß;NF-?B concentration;Thromboxane B2 concentration;Straight Leg Raise Angle;Rate of excellent efficacy;

Countries

China

Contacts

Public ContactSu Meiyi

Guangdong Second Provincial Traditional Chinese Medicine Hospital

40983489@gg.com+86 20 8358 8031

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026