Recruiting
Phase 4

Steroid Injections

Sponsor:

Igor Wilderman. MD

Code:

NCT07762170

Conditions

Back Pain Lower Back

Neck Pain

Radiculopathy Multiple Sites

Spinal Stenosis Cervicothoracic Region

Spinal Stenosis Lumbar

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

triamcinolone acetonide (Kenalog)

Celestone Soluspan 6Mg/Ml Suspension for Injection

Depo-Medrol 40Mg/Ml Suspension for Injection

Dexamethasone

Study Details

Brief 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.

Conditions

Back Pain Lower Back

Neck Pain

Radiculopathy Multiple Sites

Spinal Stenosis Cervicothoracic Region

Spinal Stenosis Lumbar

Study ID

NCT07762170

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Spinal steroid injections with methylprednisolone

active comparator: Spinal steroid injections with betamethasone

active comparator: Spinal steroid injections with dexamethasone

active comparator: Spinal steroid injections with triamcinolone

Interventions

triamcinolone acetonide (Kenalog)

Comparison of efficacy and safety of various protocols of injections for back pain

Celestone Soluspan 6Mg/Ml Suspension for Injection

Comparison of efficacy and safety of various protocols of injections for back pain

Depo-Medrol 40Mg/Ml Suspension for Injection

Comparison of efficacy and safety of various protocols of injections for back pain

Dexamethasone

Comparison of efficacy and safety of various protocols of injections for back pain

Primary outcome measure

  • Integral of pain relief [ Time Frame: 8-12 weeks, up to 6 months or one year if applicable ]
  • Numeric rating scale [ Time Frame: 2, 4, 6, 8, 12 weeks ]
  • Functional integral of pain relief [ Time Frame: 8-12 weeks, up to 6 months or one year if applicable ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - custom version [ Time Frame: 2, 4, 6, 8, 12 weeks ]
  • Patient's global impression of change (PGIC) [ Time Frame: 2, 4, 6, 8, 12 weeks ]

Central Contacts and Locations

Central contacts

Igor Wilderman, MD

905-886-1212iw@drwilderman.com

Francesca Sarzetto, MD, MSc

905-886-1212research@drwilderman.com

Locations

Wilderman Medical Clinic

Recruiting

Thornhill, Ontario, Canada, L4J 1W3

Contacts

Igor Wilderman, MD

905-886-1212iw@drwilderman.com

Francesca Sarzetto, MD, MSc

905-886-1212research@drwilderman.com

Principal Investigator:

Igor Wilderman, MD

More Information

Sponsor

Igor Wilderman. MD

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • epidural steroid injections
  • back pain treatments
  • pain relief
  • spinal steroid injections
  • spinal injections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Igor Wilderman. MD on 2026-08-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.