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Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Primary Purpose

Chronic Pain Syndrome

Status

Active

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

medthylprednisolone

prolotherapy

About this trial

This is an interventional treatment trial for Chronic Pain Syndrome focused on measuring caudal epidural, prolotherapy, steroids, failed back surgery

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ahmed S. Shehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Steroid group (Group S)

Prolotherapy group (Group P)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the level reached by the injectate

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

assess the satisfaction of the patients

further change in visual analogue scale

in the next follow up periods

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

Full Information

NCT ID

NCT05548738

First Posted

September 14, 2022

Last Updated

October 1, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05548738

Brief Title

Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain Syndrome

Keywords

caudal epidural, prolotherapy, steroids, failed back surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Masking Description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Steroid group (Group S)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Prolotherapy group (Group P)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

medthylprednisolone

Other Intervention Name(s)

steroids

Intervention Description

a type of steroids injected in epidural space

Intervention Type

Drug

Intervention Name(s)

prolotherapy

Other Intervention Name(s)

dextrose 10%

Intervention Description

a type of hypertonic glucose

Primary Outcome Measure Information:

Title

Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain

Description

A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

the level reached by the injectate

Description

by using fluoroscopy guidance

Time Frame

at time of injection

Title

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

Description

assess the satisfaction of the patients

Time Frame

6 months

Title

further change in visual analogue scale

Description

in the next follow up periods

Time Frame

2 weeks till 6 months

Title

recording the number of patients who encountered any complications and treating them accordingly

Description

such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed S shehab

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ahmed S. Shehab

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

29883193

Citation

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.

Results Reference

result

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Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

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