CompletedPhase 2/3

Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Egypt90 participantsStarted 2022-04-20

Plain-language summary

This study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain

Who can participate

Age range20 Years – 70 Years

SexALL

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Inclusion criteria

✓. patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination
✓. patients having positive radiological (MRI) findings of spinal nerve roots being irritated or compressed after having surgery for one of many conditions including: lumbar disc herniation, spinal canal stenosis, osteophytes, spodylolithesis or foramen stenosis
✓. patients whom another surgery is not indicated

Exclusion criteria

✕. patient refusal
✕. pregnancy
✕. systemic infection or infection at the site of injection
✕. patients on anticoagulation
✕. immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection
✕. patients with renal impairment or on dialysis
✕. acute disc prolapse as it requires immediate surgery
✕. opioid use

What they're measuring

Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain

Timeframe: 2 weeks

Trial details

NCT IDNCT05548738

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

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