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Updated: Nov 19, 2025

Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery
Published on: April 14, 2016
Essential statistical principles of clinical trials of pain treatments
Robert H Dworkin1, Scott R Evans2, Omar Mbowe3
1Departments of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Center for Health + Technology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Abstract:
This article presents an overview of fundamental statistical principles of clinical trials of pain treatments. Statistical considerations relevant to phase 2 proof of concept and phase 3 confirmatory randomized trials investigating efficacy and safety are discussed, including (1) research design; (2) endpoints and analyses; (3) sample size determination and statistical power; (4) missing data and trial estimands; (5) data monitoring and interim analyses; and (6) interpretation of results. Although clinical trials of pharmacologic treatments are emphasized, the key issues raised by these trials are also directly applicable to clinical trials of other types of treatments, including biologics, devices, nonpharmacologic therapies (eg, physical therapy and cognitive-behavior therapy), and complementary and integrative health interventions.
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