Opioid Induced Motor Disturbances
Conditions
Brief 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.
Detailed description
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).
Interventions
DRUGTapentadol 50 mg Oral Tablet
1 tablet administered
DRUGTramadol Hydrochloride 100 mg Extended Release Oral Tablet
1 tablet administered
DRUGPlacebo Oral Tablet
calcium tablet
Sponsors
Frederiksberg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects: * In general good health, in the opinion of the Investigator, based on medical history and physical examination. * Ability to comprehend and a willingness to provide written informed consent * Age between 50 and 75 years * No opioid usage 3 months prior to the study * No musculoskeletal pain requiring medical attention during the previous 3 months * Willing and able to complete study visits and procedures * Willing to hold activity, exercise level, and concurrent treatments/therapies generally consistent during the study * A body mass index (BMI) of ≤30 Patients with knee osteoarthritis (OA) * Diagnosis of knee OA * Ability to comprehend and a willingness to provide written informed consent * Age between 50 and 75 years * No opioid usage 3 months prior to the study * Knee pain of at least 40 mm on a 0-100 mm visual analog scale (without analgesics) representing the average pain intensity during the previous week * Willing to discontinue all pain medications 24 hours before and during examination visits * Willing and able to complete study visits and procedures * Willing to hold activity, exercise level, and concurrent treatments/therapies generally consistent during the study * In general good health, in the opinion of the Investigator, based on medical history and physical examination. * A body mass index (BMI) of ≤30
Exclusion criteria
The same
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gait variability | every hour from pre-tablet administration (hour 0) to hour 6 | Three dimensional gait analysis during 6 minutes of continuous treadmill walking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self reported dizziness | every hour from pre-tablet administration (hour 0) to hour 6 | Current dizziness is assessed by means of a 100 mm visual analog scale |
| Self reported knee pain | every hour from pre-tablet administration (hour 0) to hour 6 | Current knee pain is assessed by means of a 100 mm visual analog scale |
Countries
Denmark
Outcome results
None listed