Trial comparing intra-discal injection of ozone with platelet rich plasma (PRP) versus corticosteroid injection around the nerve versus surgical disc removal in patients suffering sciatica due to a lumbar disc herniation.
Pragmatic randomised controlled trial comparing pain levels and quality of life following intradiscal oxygen-ozone/autologous platelet rich plasma, corticosteroid injections and microdiscectomy in sciatica caused by lumbar disc herniation.
Arockia Doss
300 participants
Jun 1, 2020
Interventional
Conditions
Summary
What is this research about ? Lumbar disc herniation (LDH) also known as disc prolapse or bulge in the lower back that may cause severe pains down the leg. This research project aims to improve our understanding on the condition and choosing between surgery versus spinal injections. What is the hypothesis ? Is there any benefit when we use non surgical injections to treat sciatica from a disc herniation ? What does it mean to be part of this trial ? You will be randomly allocated a treatment option that either involves a spinal injection procedure under x-ray scanning control or spinal surgery. You will not able to choose a treatment option. Aside from this allocation, the medical care you receive is the same as that you would have received as part of standard care. At regular intervals you are required to complete forms that provide information on your symptoms and quality of life.
Eligibility
Inclusion Criteria5
- -12 weeks of sciatica defined as radicular pain below the knee in a dermatome that corresponds to a single level LDH diagnosed on MRI lumbar spine.
- Abnormal straight leg raise (<60 degree) in the ipsilateral side of disc herniation.
- Predetermined level of sciatic pain (VAS of more than 50mm/100mm).
- Sciatica bothersomeness index for leg pain of no less than 4 out of 6.
- Failed physiotherapy and oral medication as first line management.
Exclusion Criteria1
- Inability to provide consent, more than 1 level of LDH, spondylosis or lumbar stenosis on CT or MRI, workers compensation injuries, smoking, heavy manual labour, prior lumbar surgery, spinal cortisone injections, drop foot and or cauda equina syndrome, prior lumbar fracture, skeletal deformity, overweight (defined as more than 25kg/m2), carcinoma, bleeding disorder, immune deficiency, allergy to local anaesthetic medication, previous psychiatric treatment.
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Interventions
The following intervention is used once only. CT or fluoroscopy guided Oxygen Ozone and platelet rich plasma (PRP) intradiscal injections: A radiologist with more than five years consultant experience performs an intradiscal injection of 4cc of Oxygen Ozone 27microgram/ml, 6cc of peridiscal injection of O2O3, 1-3cc of autologous blood derived platelet rich plasma (PRP) into the disc and 3cc around the disc. The standard technique of injection into the nucleus pulposus with slow withdrawal of needle into the annulus and peri-annular space is performed for both ozone and PRP. A total of 6cc of PRP is used into and around the disc. This may be performed in an outpatient CT facility if all of the following are fulfilled: patients are observed in the supine and decubitus position for two hours. The patient is only discharged with an escort. CT or fluoroscopy guidance is used at the discretion of the proceduralist. PRP is typically obtained by a standard venesection with collection of 8cc of venous blood into a sterile blood collection tube (e.g. ADISTEM tubes or similar tubes approved by the Therapeutic Goods Administration of Australia for this purpose) that contains 1-2cc of sodium citrate as an anticoagulant. This is centrifuged for 5 minutes. The blood collection tube is then transferred to a clean air flow cabinet (or in the open if performed in a theatre), where the Buffy coat supernatant is aspirated into a sterile syringe in a sterile fashion for injection.
Locations(1)
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ACTRN12619001214123