Ahmed S. Shehab
Alexandria, Egypt
NCT Number: NCT05548738
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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Notify Me20 year–70 year
All sexes
Interventional
Phase 2 / Phase 3
Alexandria, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a type of steroids injected in epidural space
Other names: steroids
a type of hypertonic glucose
Other names: dextrose 10%
Time frame: 2 weeks
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
Time frame: at time of injection
by using fluoroscopy guidance
Time frame: 6 months
assess the satisfaction of the patients
Time frame: 2 weeks till 6 months
in the next follow up periods
Time frame: 6 months
such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting
Alexandria University
Other
The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
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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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