Opioid Induced Gait Variability
Overview
- Phase
- Phase 1
- Intervention
- Placebo Oral Tablet
- Conditions
- Opioid Induced Motor Disturbances
- Sponsor
- Frederiksberg University Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in Gait variability
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Henning Bliddal
Professor
Frederiksberg University Hospital
Eligibility Criteria
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)
Exclusion Criteria
- •The same exclusion criteria apply for both healthy subjects and patients with knee osteoarthritis:
- •Clinical signs of gait ataxia assessed by clinical neurological examination
- •Independent or unsteady walking (i.e. dependence on walking device or stumbling gait)
- •Counter indications to either of the investigational products, including but not restricted to:
- •Allergy towards one or more of the investigational products or their excipient(s).
- •Significant respiratory depression
- •Current or serious asthma
- •Hypercapnia
- •Suspected or diagnosed paralytic ileus
- •Acute intoxication by alcohol, hypnotica, centrally acting analgesics, psychopharmaca or other pharmaceuticals.
Arms & Interventions
Placebo oral tablet
One inert calcium tablet is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements.
Intervention: Placebo Oral Tablet
Tramadol Hydrochloride 100 mg Extended Release Oral Tablet
One tablet containing 100 milligrams (mg) Mandolgin Retard, Sandoz is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements.
Intervention: Tramadol Hydrochloride 100 mg Extended Release Oral Tablet
Tapentadol 50 mg Oral Tablet
One tablet containing 50 milligrams (mg) Palexia Depot, Grünenthal is administered after a set of baseline measurements are performed. Subsequently outcomes are assessed every hour for 6 hours, yielding a total of 7 hourly measurements.
Intervention: Tapentadol 50 mg Oral Tablet
Outcomes
Primary Outcomes
Changes in Gait variability
Time Frame: every hour from pre-tablet administration (hour 0) to hour 6
Three dimensional gait analysis during 6 minutes of continuous treadmill walking.
Secondary Outcomes
- Self reported knee pain(every hour from pre-tablet administration (hour 0) to hour 6)
- Self reported dizziness(every hour from pre-tablet administration (hour 0) to hour 6)