The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome

0201626

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

2022-04-20

2023-11-30

2024-06-01

Active (not recruiting)

Early phase I

80

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-02-28