Health TrialsbyHealthPanel

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

ConditionsBack Pain Lower BackNeck PainRadiculopathy Multiple SitesSpinal Stenosis Cervicothoracic RegionSpinal Stenosis LumbarFailed Back Surgery Syndrome (FBSS)SciaticaIntervertebral Disc Disorders With Radiculopathy, Lumbar RegionSpine Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIgor Wilderman. MD

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • triamcinolone acetonide (Kenalog)

    Drug

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

  • Celestone Soluspan 6Mg/Ml Suspension for Injection

    Drug

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

  • Depo-Medrol 40Mg/Ml Suspension for Injection

    Drug

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

  • Dexamethasone

    Drug

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

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Spinal steroid injections with methylprednisoloneActive comparator 1 intervention
Group B: Spinal steroid injections with betamethasoneActive comparator 1 intervention
Group C: Spinal steroid injections with dexamethasoneActive comparator 1 intervention
Group D: Spinal steroid injections with triamcinoloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Integral of pain relief

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

Time frame
8-12 weeks, up to 6 months or one year if applicable
2

Numeric rating scale

Scale from 0 to 10 assessing the pain intensity

Time frame
2, 4, 6, 8, 12 weeks
3

Functional integral of pain relief

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

Time frame
8-12 weeks, up to 6 months or one year if applicable
4

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).

Time frame
2, 4, 6, 8, 12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Igor Wilderman. MD

Lead sponsor

Wilderman Medical Clinic

Sponsor institution

Source ClinicalTrials.gov
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