Lumbar and other intervertebral disc disorders with radiculopathy (G55.1*), including sciatica due to intervertebral disc disorder
Conditions
Interventions
Intervention group: Each participant will receive a single intradiscal injection of 2 mL autologous platelet-rich plasma (PRP) prepared from 30 mL of the patient’s venous blood using a two-step centri
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 25–65 years. Chronic low back pain =6 months. MRI-confirmed lumbar disc protrusion at L4–L5 or L5–S1 (single target level). Discogenic pain phenotype without clinical radiculopathy. Failed standard conservative therapy (e.g., NSAIDs, physiotherapy). Baseline VAS =5/10. Oswestry Disability Index (ODI) =30%. No Modic type I or II changes at the target level on MRI. Written informed consent.
Exclusion criteria
Exclusion criteria: Severe disc degeneration (Pfirrmann grade IV or V) Presence of Modic type I or II changes at the target level. History of lumbar spine surgery. Radiculopathy or neurological deficits (e.g., weakness, numbness, bladder/bowel dysfunction). Active infection or systemic inflammatory disease. Coagulopathy or platelet count <150,000/µL. Current anticoagulant or antiplatelet therapy. Pregnancy or breastfeeding. Severe psychiatric or cognitive disorders interfering with consent or follow-up. Malignancy, autoimmune disease, or uncontrolled diabetes. Allergy to local anesthetics or procedure materials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity measured by the Visual Analog Scale (VAS) from baseline to 6 months after intradiscal PRP injection. Timepoint: ChatGPT said:Before intervention (baseline) and at 1 month, 3 months, and 6 months after intradiscal PRP injection. Method of measurement: ChatGPT said:Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter scale where 0 represents no pain and 10 represents the worst imaginable pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in functional disability measured by the Oswestry Disability Index (ODI) from baseline to 6 months after intradiscal PRP injection. Timepoint: Before intervention (baseline) and at 1 month, 3 months, and 6 months after intradiscal PRP injection. Method of measurement: ChatGPT said:Functional disability will be measured using the Oswestry Disability Index (ODI), a validated questionnaire assessing limitations in daily activities on a scale from 0% (no disability) to 100% (maximum disability). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNima Amiresmaili
Tehran University of Medical Sciences
Outcome results
None listed