drugset / Trial / NCT03121547

Opioid Induced Gait Variability

NCT03121547

Phase 1/2 Completed 24 enrolled Frederiksberg University Hospital
RandomizedCrossoverTriple-blindBasic science

Summary

While the analgesic effects of opioids are well known, evidence suggest that there are differences in the adverse dizziness of the different opioid types, which may influence the gait function differently. However, this has not been investigated scientifically under controlled conditions. Normal gait function is characterized by cyclic movements with a high degree of predictability. As such, the amount of kinematic variability can provide important information about a condition or an intervention that may affect the gait function . Three-dimensional gait analysis is a recognized method to assess changes in stride-to-stride variability associated with a medical condition or caused by an intervention. Thus, opioid induced changes in gait variability, and possible differences between opioid types, can be assessed objectively from differences in the variability of movements obtained from a three-dimensional gait analysis. The purpose of this study is to investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.

Timeline

Start
2015-05-19
Primary completion
2016-01-29
Completion
2016-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Tapentadol Small molecule 50 mg Oral
Subject Tramadol Other / unclassified 100 mg Oral