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Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

CompletedPhase 2, Phase 3NCT05548738
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
Interventions
  • Drug: medthylprednisolone
  • Drug: prolotherapy
Sponsor
Alexandria University
Start date
2022-04-20
Primary completion
2023-11-30
Sex
All
Age range
from 20 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
Egypt
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination 2. 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 3. patients whom another surgery is not indicated Exclusion Criteria: 1. patient refusal 2. pregnancy 3. systemic infection or infection at the site of injection 4. patients on anticoagulation 5. immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection 6. patients with renal impairment or on dialysis 7. acute disc prolapse as it requires immediate surgery 8. opioid use 9. concurrent significant depressive illness, inflammatory of joint disease.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05548738