EFFECT OF AUTOLOGOUS PLATELET-RICH PLASMA (YELLOW BLOOD) IN PATIENTS OF LOW BACK PAIN DUE TO DISC PROLAPSED

AUTOLOGOUS PLATELET-RICH PLASMA (PRP) IN LOW BACK PAIN FOR PROLAPSED INTERVERTEBRAL DISC- INITIAL EXPLORATION IN A PROSPECTIVE RANDOMIZED CONTROL TRIAL SETTING - PRP

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027879

Enrollment

Registered

2020-09-17

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: PERIDISCAL INJECTION OF AUTOLOGOUS PLATELET RICH PLASMA: Fluoroscopy guided peridiscal (Transforaminal, KambinÃ¢â?¬â?¢s triangle approach) injection of PRP (3ml) Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years 2. Low back pain due to intervertebral disc herniation with or without radiation to lower limb, not responding to conservative treatment with NRS >6/10 3. Duration of pain more than 3 months 4. MRI evidence of lumbar disc herniation

Exclusion criteria

Exclusion criteria: 1. Refusal of patient or relatives. 2. Allergic to local anaesthetic and/or radiographic contrast agent. 3. Severe systemic diseases (DM/HTN/CAD/Valvular heart disease/Respiratory disease/Neuromuscular disorders/Epilepsy). 4. Coagulopathy or patients on anticoagulants. 5. Local site infection. 6. Pregnancy. 7. Any spinal deformity or fracture and raised intracranial pressure. 8. History of previous back surgery or implant insertion. 9. Severe psychiatric illness. 10. Red flag sign.

Design outcomes

Primary

Measure	Time frame
To compare the pain score measured by visual analogue scale (VAS)/numerical rating scale (NRS)Timepoint: Baseline,15 days, 1 month, 2 months, 3 months and 6 months	—

Secondary

Measure	Time frame
6) If the differences are found to be clinically significant but statistically non-significant, the effect size seen will be used to design a large confirmatory RCT.Timepoint: After 6 month;Assessment of treatment response on the basis of Global perceived effect (GPE) scaleTimepoint: Baseline, 15 days, 1 month, 2 months, 3 months and 6 months;To compare blood serum level of erythrocyte sedimentation rate (ESR), High-sensitivity C-reactive protein (hs-CRP), interleukins (IL-4), Tumour necrosis factor alpha (TNF alpha), Interferon gamma (IFN-Ã?Â³) in both groupsTimepoint: Base line, 1 month and 3 months;To compare radiological changes in MRI lumber spineTimepoint: Baseline and 6 months;To compare the functional status by modified oswestry low back pain disability questionnaire (MODQ) and straight leg raising test (SLRT)Timepoint: Baseline, 15 days, 1 month, 2 months, 3 months and 6 months	—

Measure

Time frame

6) If the differences are found to be clinically significant but statistically non-significant, the effect size seen will be used to design a large confirmatory RCT.Timepoint: After 6 month;Assessment of treatment response on the basis of Global perceived effect (GPE) scaleTimepoint: Baseline, 15 days, 1 month, 2 months, 3 months and 6 months;To compare blood serum level of erythrocyte sedimentation rate (ESR), High-sensitivity C-reactive protein (hs-CRP), interleukins (IL-4), Tumour necrosis factor alpha (TNF alpha), Interferon gamma (IFN-Ã?Â³) in both groupsTimepoint: Base line, 1 month and 3 months;To compare radiological changes in MRI lumber spineTimepoint: Baseline and 6 months;To compare the functional status by modified oswestry low back pain disability questionnaire (MODQ) and straight leg raising test (SLRT)Timepoint: Baseline, 15 days, 1 month, 2 months, 3 months and 6 months

—

Countries

India

Contacts

Public ContactGIRISH KUMAR SINGH

ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH

praveenrt64@gmail.com9654162941

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026