Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

NCT05548738 | Completed Phase 2 DMC

• 1 other identifier: 0201626
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain Syndrome

Keywords

caudal epidural; prolotherapy; steroids; failed back surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

Steroid group (Group S)

ACTIVE COMPARATOR

This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection

Drug: medthylprednisolone

Prolotherapy group (Group P)

EXPERIMENTAL

This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection

Drug: prolotherapy

Interventions

medthylprednisolone DRUG

a type of steroids injected in epidural space

Also known as: steroids

Steroid group (Group S)

prolotherapy DRUG

a type of hypertonic glucose

Also known as: dextrose 10%

Prolotherapy group (Group P)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ahmed S. Shehab

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29883193 RESULT

MeSH Terms

Interventions

Steroids; Prolotherapy

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Complementary Therapies; Therapeutics

Study Officials

• Ahmed S shehab

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Anaesthesia and Surgical ICU department

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: April 20, 2022
• Primary Completion: November 30, 2023
• Study Completion: June 30, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study ends upon request
• Access Criteria: Accessible through the web site

Locations

EG (1)