Home/Get Matched/NCT07762170
Phase 4Recruiting
View on ClinicalTrials.gov

Comparing 4 approaches for back pain lower back

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

Success Rates and Safety in Managing Spinal and Sacro-Iliac Pain: A Critical Analysis

Condition: Back Pain Lower BackSponsor: Igor Wilderman. MDTarget enrollment: 500
  • Phase 4
  • 4 groups
  • One site, in Thornhill
  • Recruiting
Wilderman Medical Clinic, Thornhill, Ontario

Interventions (4)

  • Medication

    triamcinolone acetonide (Kenalog)

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

  • Medication

    Celestone Soluspan 6Mg/Ml Suspension for Injection

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

  • Medication

    Depo-Medrol 40Mg/Ml Suspension for Injection

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

Canadian Sites (1)

1 of 1 recruiting

  • Wilderman Medical Clinic

    Thornhill, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +\>18 years of age;
  • +Diagnosis of lumbar, cervical, or thoracic pain with various etiologies;
  • +EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more → points after the intervention;
  • +Provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.

Exclusion

  • Diagnosis of dementia, Parkinson's disease or other cognitive impairments;
  • Congenital or acquired polyneuropathy;
  • Any clinically significant acute or chronic medical condition that in the judgment of InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and during the study period.
  • Back surgery in the month before injection treatment or planned surgery in the subsequent 3 months;
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 4 groups in this study.

Group A, the comparison group, receives Depo-Medrol 40Mg/Ml Suspension for Injection.

Registry label: A: Spinal steroid injections with methylprednisolone

Group B, the comparison group, receives Celestone Soluspan 6Mg/Ml Suspension for Injection.

Registry label: B: Spinal steroid injections with betamethasone

Group C, the comparison group, receives Dexamethasone.

Registry label: C: Spinal steroid injections with dexamethasone

Group D, the comparison group, receives triamcinolone acetonide (Kenalog).

Registry label: D: Spinal steroid injections with triamcinolone

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 500 people.

The study is currently expected to finish around March 2030.

The main measurement is taken over: 8-12 weeks, up to 6 months or one year if applicable.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Integral of pain relief — measured over 8-12 weeks, up to 6 months or one year if applicable.

Numeric rating scale — measured over 2, 4, 6, 8, 12 weeks.

Functional integral of pain relief — measured over 8-12 weeks, up to 6 months or one year if applicable.

Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - custom version — measured over 2, 4, 6, 8, 12 weeks.

The study lists 1 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07762170 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About triamcinolone acetonide (Kenalog)Drug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Celestone Soluspan 6Mg/Ml Suspension for InjectionDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Depo-Medrol 40Mg/Ml Suspension for InjectionDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About DexamethasoneDrug

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

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 8-12 weeks, up to 6 months or one year if applicable.

The study as a whole is currently expected to finish around 2030-03.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 500 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Thornhill, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.