Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chronic Pain Syndrome

Intervention / Treatment
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* Drug: medthylprednisolone
* Drug: prolotherapy


Participation Criteria
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Eligibility Criteria
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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 concurrent significant depressive illness, inflammatory of joint disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid group (Group S)<br>This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection | Drug: medthylprednisolone<br>* a type of steroids injected in epidural space<br>* Other names: steroids;|
| Experimental: Prolotherapy group (Group P)<br>This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection | Drug: prolotherapy<br>* a type of hypertonic glucose<br>* Other names: dextrose 10%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain | A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the level reached by the injectate | by using fluoroscopy guidance | 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 | assess the satisfaction of the patients | 6 months | 
| further change in visual analogue scale | in the next follow up periods | 2 weeks till 6 months | 
| recording the number of patients who encountered any complications and treating them accordingly | such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caudal epidural, prolotherapy, steroids, failed back surgery