Opioid Induced Motor Disturbances Clinical Trial
Official title:
Opioid Induced Gait Variability
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.
The study is designed as an experimental single center, double-blind treatment, cross-over
study with inert placebo, Tapentadol (Palexia Depot), and Tramadolhydrochlorid (Mandolgin
Retard), with a minimum of 7days wash-out periods.
At day 1 (Visit 1), baseline measurements are carried out before tablet administration.
Immediately after baseline measurements one tablet is administered, and hourly measurements
are performed for 6 hours. Subsequently all participants enter a minimum 7 day washout
period, after which they return to the facility to repeat the procedures at Visit 2 (day 8+)
and Visit 3 (day 15+). The order of treatments will be randomized (1:1:1).
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