Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

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

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 Overview

• Status: Completed
• Conditions: Chronic Pain Syndrome
• Intervention / Treatment: Drug: medthylprednisolone; Drug: prolotherapy

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Ahmed S. Shehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Ahmed S shehab, Alexandria University

Publications and helpful links

General Publications

• Maniquis-Smigel L, Reeves KD, Rosen HJ, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. J Altern Complement Med. 2018 Dec;24(12):1189-1196. doi: 10.1089/acm.2018.0085. Epub 2018 Jun 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: steroids; prolotherapy; caudal epidural; failed back surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Disease; Back Pain; Syndrome; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 0201626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
• IPD Sharing Time Frame: After study ends upon request
• IPD Sharing Access Criteria: Accessible through the web site
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No