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Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)

RECRUITINGPhase 4Sponsored by Igor Wilderman. MD
Actively Recruiting
PhasePhase 4
SponsorIgor Wilderman. MD
Started2026-07-30
Est. completion2029-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07762170

Summary

This study aims to analyze the efficacy and safety of different kinds of steroid injections for back pain, comparing different steroids, dosages, locations (epidural, facet joints, nerve blocks), and also the difference between injections with steroids and local anesthetics, to optimize this treatment that is currently not standardized. The investigators will compare retrospectively and prospectively the efficacy of different injections in the same patients, using mainly a parameter called integral of pain relief, which combines the percentage of pain relief provided by a treatment and its duration over time, as well as improvements in functionality.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* \>18 years of age;
* Diagnosis of lumbar, cervical, or thoracic pain with various etiologies;
* Eligibility to receive steroid injections for back pain, including epidural, facet joints, or SIJ injections, or other injections (e.g., local anesthetics);
* Being willing and able to provide NRS pain ratings and PROMIS functionality ratings before the intervention, and the same scores plus IPR, fIPR, and PGIC at various follow-up points after the intervention;
* Provide written informed consent.

Exclusion Criteria:

* Diagnosis of dementia, Parkinson's disease or other cognitive impairments;
* Congenital or acquired polyneuropathy;
* Back surgery in the month before injection treatment or planned surgery in the subsequent 3 months;
* Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude injection in the epidural space or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study;
* Participation in any other competing clinical study within 3 months prior to screening and during the study period.

Conditions10

ArthritisBack Pain Lower BackFailed Back Surgery Syndrome (FBSS)Intervertebral Disc Disorders With Radiculopathy, Lumbar RegionNeck PainRadiculopathy Multiple SitesSciaticaSpinal Stenosis Cervicothoracic RegionSpinal Stenosis LumbarSpine Osteoarthritis

Interventions4

Celestone Soluspan 6Mg/Ml Suspension for InjectionDepo-Medrol 40Mg/Ml Suspension for InjectionDexamethasonetriamcinolone acetonide (Kenalog)

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