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Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Integral of pain relief — 8-12 weeks, up to 6 months or one year if applicable parameter obtained by multiplying the percentage of pain relief provided by a treatment by the number of days of relief
Numeric rating scale — 2, 4, 6, 8, 12 weeks Scale from 0 to 10 assessing the pain intensity
Functional integral of pain relief — 8-12 weeks, up to 6 months or one year if applicable Percentage of functionality improvements multiplied by the number of days of improvement duration
Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - custom version — 2, 4, 6, 8, 12 weeks 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).
Patient's global impression of change (PGIC) — 2, 4, 6, 8, 12 weeks 7-grade scale representing the overall assessment of change perceived by the patient, from Very Much Improved to Very Much Worsened
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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