MedTrace Logo

Opioid Induced Gait Variability

NCT03121547 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Opioid Induced Motor Disturbances

Interventions

DRUG

Tapentadol 50 mg Oral Tablet

1 tablet administered

DRUG

Tramadol Hydrochloride 100 mg Extended Release Oral Tablet

1 tablet administered

DRUG

Placebo Oral Tablet

calcium tablet

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Henning Bliddal, DMSc · The Parker Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03121547 on ClinicalTrials.gov