The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
Study Overview
Brief 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
Detailed Description
This study is a prospective double blinded randomized controlled study. It will be held on patients with failed back surgery syndrome aged between 20 and 70 years old, one group will receive ultrasound and fluoroscopy-guided injection of prolotherapy in caudal epidural space while the other group will receive ultrasound and fluoroscopy-guided injection of steroids in the caudal epidural space 40 patients will be included in each group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •concurrent significant depressive illness, inflammatory of joint disease.
Arms & Interventions
Steroid group (Group S)
This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection
Intervention: medthylprednisolone (Drug)
Prolotherapy group (Group P)
This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection
Intervention: prolotherapy (Drug)
Outcomes
Primary Outcomes
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
Time Frame: 2 weeks
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
Secondary Outcomes
- further change in visual analogue scale(2 weeks till 6 months)
- recording the number of patients who encountered any complications and treating them accordingly(6 months)
- the level reached by the injectate(at time of injection)
- assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS) from 0 to 28 where 0 is so dissatisfied and 28 means very satisfied(6 months)
Investigators
Ahmed Shehab, MD
Lecturer in Anaesthesia and Surgical ICU department
Alexandria University