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

NCT07762170 | Recruiting Phase 4 FDA Drug

• 1 other identifier: WMC004
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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; Failed Back Surgery Syndrome (FBSS); Sciatica; Intervertebral Disc Disorders With Radiculopathy, Lumbar Region; Spine Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Integral of pain relief

  parameter obtained by multiplying the percentage of pain relief provided by a treatment by the number of days of relief

  8-12 weeks, up to 6 months or one year if applicable

• Numeric rating scale

  Scale from 0 to 10 assessing the pain intensity

  2, 4, 6, 8, 12 weeks

• Functional integral of pain relief

  Percentage of functionality improvements multiplied by the number of days of improvement duration

  8-12 weeks, up to 6 months or one year if applicable

• Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - custom version

  Customized PROMIS questionnaire to assess the overall functional status: 12 questions, each with scores variable between 5 (no difficulty or best possible situation, depending on the question ) and 1 (unable to do or worst case scenario). Four questions relate to physical function, two to fatigue, one to sleep quality, two to mood, two to social roles and activity, and one to pain interference with general activities. The maximum score (no problem) is 60, and the minimum is 12 (severely incapacitated).

  2, 4, 6, 8, 12 weeks

• Patient's global impression of change (PGIC)

  7-grade scale representing the overall assessment of change perceived by the patient, from Very Much Improved to Very Much Worsened

  2, 4, 6, 8, 12 weeks

Study Arms (4)

Spinal steroid injections with methylprednisolone

ACTIVE COMPARATOR

Drug: Depo-Medrol 40Mg/Ml Suspension for Injection

Spinal steroid injections with betamethasone

ACTIVE COMPARATOR

Drug: Celestone Soluspan 6Mg/Ml Suspension for Injection

Spinal steroid injections with dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Spinal steroid injections with triamcinolone

ACTIVE COMPARATOR

Drug: triamcinolone acetonide (Kenalog)

Interventions

triamcinolone acetonide (Kenalog) DRUG

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

Also known as: epidural steroid injections, interlaminar steroid injections, facet joints steroid injections, sacroiliac steroid injections, caudal steroid injections

Spinal steroid injections with triamcinolone

Celestone Soluspan 6Mg/Ml Suspension for Injection DRUG

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

Also known as: epidural steroid injections, caudal steroid injections, interlaminar steroid injections, facet joint steroid injections, sacroiliac steroid injections

Spinal steroid injections with betamethasone

Depo-Medrol 40Mg/Ml Suspension for Injection DRUG

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

Also known as: epidural steroid injections, caudal steroid injections, interlaminar steroid injections, facet joints steroid injections, sacroiliac steroid injections

Spinal steroid injections with methylprednisolone

Dexamethasone DRUG

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

Also known as: epidural steroid injections, caudal steroid injections, interlaminar steroid injections, facet joints steroid injections, sacroiliac steroid injections

Spinal steroid injections with dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Igor Wilderman. MD: lead

Study Sites (1)

Wilderman Medical Clinic

Thornhill, Ontario, L4J 1W3, Canada

RECRUITING

Related Publications (2)

• Wilderman I, Sarzetto F, Didari T, Manor RF, Riabi SKG. Safety and Effectiveness of Different Approaches for Epidural Steroid Injections in Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis. Pain Physician. 2026 Jul;29(5):E337-E361.

  PMID: 42550520 BACKGROUND

• Wilderman I, Zingerman O, Sarzetto F, Tsirulnikov M, Nezon E. Validation of the integral of pain relief as a measure of chronic pain treatment efficacy. Pain Rep. 2025 Dec 12;11(1):e1373. doi: 10.1097/PR9.0000000000001373. eCollection 2026 Feb.

  PMID: 41404364 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Failed Back Surgery Syndrome; Sciatica; Osteoarthritis, Spine

Interventions

Triamcinolone Acetonide; betamethasone acetate phosphate; Suspensions; Injections; Methylprednisolone Acetate; Dexamethasone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Methylprednisolone; Prednisolone; Pregnadienetriols

Study Officials

• Igor Wilderman, MD

  Canadian Centre for Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Wilderman, MD

CONTACT

905-886-1212; iw@drwilderman.com

Francesca Sarzetto, MD, MSc

CONTACT

905-886-1212; research@drwilderman.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Retrospective and prospective comparison of different spinal injections for back pain in the same patients

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 13, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CA (1)