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Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

NCT ID: NCT05548738

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2024-06-30

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

Conditions

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Chronic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Steroid group (Group S)

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

Group Type ACTIVE_COMPARATOR

medthylprednisolone

Intervention Type DRUG

a type of steroids injected in epidural space

Prolotherapy group (Group P)

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

Group Type EXPERIMENTAL

prolotherapy

Intervention Type DRUG

a type of hypertonic glucose

Interventions

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medthylprednisolone

a type of steroids injected in epidural space

Intervention Type DRUG

prolotherapy

a type of hypertonic glucose

Intervention Type DRUG

Other Intervention Names

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steroids dextrose 10%

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Shehab, MD

Lecturer in Anaesthesia and Surgical ICU department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed S shehab

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Ahmed S. Shehab

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 29883193 (View on PubMed)

Other Identifiers

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0201626

Identifier Type: -

Identifier Source: org_study_id