Evaluating IMMPACT Criteria for the Clinical Meaningfulness of Between-Group Differences: Interpreting Randomized Trial Results within a Context of Existing Chronic Pain Analgesics.
9 affiliations
- 1Alivio Clinical Consulting, Chicago, IL, USA.
- 2Clinical Development, Medical Affairs, and Regulatory Affairs, Consultants to Scilex Holding Company, Palo Alto, CA, USA.
- 3Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
- 4Department of Anesthesiology and Pain Management, University of Miami Miller School of Medicine, Miami, FL, USA.
- 5Department of Anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, IL, USA.
- 6Department of Anesthesiology and Department of Surgery, University of Illinois, Chicago, IL, USA.
- 7Summit Analytical LLC, Denver, CO, USA.
- 8Clinical Development, Scilex Holding Company, Palo Alto, CA, USA.
- 9Ein Sof Innovation, Wellesley, MA, USA.
Abstract
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has published methods and consensus benchmarks for determining the clinical meaningfulness of analgesic clinical trial results. However, results are commonly misinterpreted when within-subject thresholds for clinical meaningfulness are applied to between-group differences (ie, active vs placebo). IMMPACT has emphasized that between-group differences must be interpreted on a case-by-case basis and previously published a qualitative framework that is informed by quantitative analyses, drawing on data from within an individual study together with external sources. We tested this framework by applying it to a recently completed Phase 3 clinical study (the CLEAR Trial), which assessed the efficacy and safety of SP-102-a viscous dexamethasone product for transforaminal (TF) epidural administration-versus placebo for the treatment of lumbosacral radicular pain (LRP). To contextualize the efficacy results, we conducted a narrative review and comparative analysis of all FDA-approved pharmaceutical products for chronic pain conditions and of off-label TF steroid injection studies. This article presents conclusions regarding both the utility of the IMMPACT framework and the clinical meaningfulness of the results of the example trial. Implementing the framework was generally straightforward, although it required user discretion in several areas and exposed several limitations within both the framework itself and the underlying clinical study data. Based on the IMMPACT framework, SP-102 appears to provide a clinically meaningful benefit in between-group comparisons.
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BibTeX
@article{meske2026evaluating,
title = {{Evaluating IMMPACT Criteria for the Clinical Meaningfulness of Between-Group Differences: Interpreting Randomized Trial Results within a Context of Existing Chronic Pain Analgesics.}},
author = {Diana S Meske and Robert H Dworkin and Jeffrey Gudin and Nebojsa Nick Knezevic and Mark J Jaros and Kip Vought and Dmitri Lissin and Nathaniel Katz},
journal = {Journal of pain research},
year = {2026},
month = oct,
doi = {10.2147/jpr.s628598},
url = {https://europepmc.org/article/MED/42898904},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Evaluating IMMPACT Criteria for the Clinical Meaningfulness of Between-Group Differences: Interpreting Randomized Trial Results within a Context of Existing Chronic Pain Analgesics.
AU - Diana S Meske
AU - Robert H Dworkin
AU - Jeffrey Gudin
AU - Nebojsa Nick Knezevic
AU - Mark J Jaros
AU - Kip Vought
AU - Dmitri Lissin
AU - Nathaniel Katz
PY - 2026
DA - 2026/10/15
JO - Journal of pain research
DO - 10.2147/jpr.s628598
UR - https://europepmc.org/article/MED/42898904
AB - The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has published methods and consensus benchmarks for determining the clinical meaningfulness of analgesic clinical trial results. However, results are commonly misinterpreted when within-subject thresholds for clinical meaningfulness are applied to between-group differences (ie, active vs placebo). IMMPACT has emphasized that between-group differences must be interpreted on a case-by-case basis and previously published a qualitative framework that is informed by quantitative analyses, drawing on data from within an individual study together with external sources. We tested this framework by applying it to a recently completed Phase 3 clinical study (the CLEAR Trial), which assessed the efficacy and safety of SP-102-a viscous dexamethasone product for transforaminal (TF) epidural administration-versus placebo for the treatment of lumbosacral radicular pain (LRP). To contextualize the efficacy results, we conducted a narrative review and comparative analysis of all FDA-approved pharmaceutical products for chronic pain conditions and of off-label TF steroid injection studies. This article presents conclusions regarding both the utility of the IMMPACT framework and the clinical meaningfulness of the results of the example trial. Implementing the framework was generally straightforward, although it required user discretion in several areas and exposed several limitations within both the framework itself and the underlying clinical study data. Based on the IMMPACT framework, SP-102 appears to provide a clinically meaningful benefit in between-group comparisons.
SN - 1178-7090
ER -