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.

Phase 4

• Conditions: umbar disc herniation; Sciatica; Lumbar disc herniation; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001214123
• Lead Sponsor: Arockia Doss

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-02
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

6-12 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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in 100mm VAS pain score<br><br>[baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks <br>];<br>2. Change in Sciatica bothersomeness index (SBI) (Proportion of participants with at least a 30% improvement in Sciatica Bothersomeness index). [baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks ];3. Change in Maine Seattle short questionnaire (MSSQ). <br><br>[baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks ]

Secondary Outcome Measures

Name	Time	Method
<br>Change in modified Oswestry Disability Index (mODI) [baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), 26 weeks and 52 weeks ];Rate of recurrent lumbar disc herniation (LDH). (repeat MRI scans) <br>[ 26 weeks and 52 weeks post first procedure];Rate of repeat injections (counting any injections subsequent to the first procedure from patient notes, booking information)<br>[ 26 weeks and 52 weeks after first procedure];Redo spinal surgery including microdiscectomy, laminectomy, lumbar fusion by checking operative notes. .<br>[ 26 weeks and 52 weeks post first procedure]