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Completed

NCT Number: NCT05548738

Caudal Epidural Prolotherapy Versus Steroids 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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ahmed S. Shehab

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

medthylprednisolone

Drug

a type of steroids injected in epidural space

Other names: steroids

prolotherapy

Drug

a type of hypertonic glucose

Other names: dextrose 10%

Primary outcomes

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

    Time frame: 2 weeks

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

Secondary outcomes

  1. the level reached by the injectate

    Time frame: at time of injection

    by using fluoroscopy guidance

  2. 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

    Time frame: 6 months

    assess the satisfaction of the patients

  3. further change in visual analogue scale

    Time frame: 2 weeks till 6 months

    in the next follow up periods

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 21, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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