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Related Concept Videos

Clinical Trials01:16

Clinical Trials

9.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
9.5K
Analgesia and Pain Management01:25

Analgesia and Pain Management

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Pain is critical to various clinical pathologies, provoking an urgent need for effective management. Pain, whether acute or chronic, is a complex neurochemical process. Its alleviation depends on the type, with nonopioid analgesics effective for mild to moderate pain, such as musculoskeletal or inflammatory pain, while neuropathic pain responds best to anticonvulsants, tricyclic antidepressants, or serotonin/norepinephrine reuptake inhibitors. For severe acute or chronic pain, opioids may be...
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Related Experiment Video

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Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
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Study Design Characteristics and Endpoints for Enriched Enrollment Randomized Withdrawal Trials for Chronic Pain

David J Kopsky1,2,3, Karolina M Szadek1, Patrick Schober1

  • 1Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, 1081 HV, the Netherlands.

Journal of Pain Research
|February 25, 2022
PubMed
Summary

Enriched enrollment randomized withdrawal trials for chronic pain should use numerical rating scales (NRS) as the primary endpoint. Time to loss of therapeutic response (LTR) is recommended as a secondary endpoint due to variability in definitions.

Keywords:
EERW trialsanalgesicsendpointspainsystematic review

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Area of Science:

  • Pain research
  • Clinical trial methodology
  • Pharmacology

Background:

  • Enriched enrollment randomized withdrawal (EERW) trials select pain responders for efficacy assessment.
  • Current EERW trials lack standardized primary endpoint recommendations.
  • Chronic pain management requires reliable efficacy measures.

Purpose of the Study:

  • To propose evidence-based recommendations for primary endpoints in EERW pain trials.
  • To assess current trial characteristics, endpoints, and effect sizes in EERW studies.
  • To improve the standardization and reliability of EERW pain trial outcomes.

Main Methods:

  • Systematic review of EERW trials comparing analgesics to placebo in chronic pain.
  • Searched electronic databases up to June 2020.
  • Analyzed 28 trials (13,662 patients in open/single-blind, 7,937 in double-blind phases).

Main Results:

  • Pain intensity (VAS/NRS) was the primary endpoint in 18 trials.
  • Time to loss of therapeutic response (LTR) was the primary endpoint in 8 trials, with varied definitions.
  • Trials using NRS/VAS reported 50% pain relief rates more consistently than those using time to LTR.

Conclusions:

  • Recommend using the numerical rating scale (NRS) as the primary endpoint in EERW pain trials.
  • Advocate for conservative imputation methods for NRS data.
  • Suggest time to loss of therapeutic response (LTR) as a valuable secondary endpoint.