Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Phase 2

Completed

• Conditions: Chronic Pain Syndrome
• Interventions: Drug: medthylprednisolone; Drug: prolotherapy

• Registration Number: NCT05548738
• Lead Sponsor: Alexandria University

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 Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-17
• Study First Posted: 2022-09-21
• Primary Completion: 2023-11-30
• Study Completion: 2024-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid group (Group S)	medthylprednisolone	This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection
Prolotherapy group (Group P)	prolotherapy	This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ahmed S. Shehab; 🇪🇬 Alexandria, Egypt