Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45-80
SponsorBenedict Alter
About this trial
The goal of this clinical trial is to examine the effects of duloxetine on walking ability and physical activity in patients with knee osteoarthritis. Researchers will compare duloxetine to a placebo (a look-alike substance that contains no drug) to see if duloxetine works to improve walking ability in patients with knee osteoarthritis. At study visits, participants will complete surveys, perform physical function tasks, undergo non-invasive brain imaging, and undergo sensory testing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Knee pain for greater than 6 months.
Moderate-to-severe knee pain (>3/10) due to osteoarthritis, as defined by American College of Rheumatology and EULAR diagnostic criteria (Zhang 2010, Altman 1986) on >50% of days in the past month.
KL grade 2-4 (Kellgren and Lawrence 1957) indicating significant degenerative changes on knee X-ray. This will be determined on evaluation of weight-bearing clinical X-rays on review of medical records. In the infrequent situation that the patient does not have an X-ray on review of their medical records, then the patient will obtain weight-bearing knee X-rays as part of the Screening Visit.
Age: 45-80 years old
Disqualifiers
Inflammatory arthritis (e.g. rheumatoid arthritis).
More intense pain due to another chronic pain syndrome (e.g. fibromyalgia, hip osteoarthritis)
Significant pain or weakness in the lower extremities due to a neurological condition (e.g. lumbar radiculopathy, paresis due to stroke)
New, ongoing acute pain
Trial design
Design model
Crossover
Treatments tested in this trial
Duloxetine
DrugDuloxetine is an FDA-approved treatment for osteoarthritis. The drug will be prescribed for subjects with knee osteoarthritis pain to improve pain during mobility. The treatment consists of 30 mg of encapsulated duloxetine by mouth once daily for one week followed by 60 mg of encapsulated duloxetine by mouth once daily for 4 weeks. Then, patients will taper back down to 30 mg of encapsulated duloxetine by mouth once daily for one week.
Placebo
DrugThe placebo is a capsule that has been filled with an inactive filler, microcrystalline cellulose (Avicel). It will match in look to the overencapsulated duloxetine capsules but not contain the duloxetine itself. Participants will take 1 week of the placebo pill identical in appearance to encapsulated duloxetine 30 mg followed by 4 weeks of the placebo pill identical in appearance to encapsulated duloxetine 60 mg. Then, patients will take one week of the placebo pill identical in appearance to encapsulated duloxetine 30 mg.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: Duloxetine, then placeboExperimental treatment 2 interventions
Group B: Placebo, then duloxetineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Distance walked in the 6-minute walking test
Distance walked during 6 minute walking task
Time frame
6 minutes per measurement; measured several times from enrollment to last study visit for up to 16 weeks.Other outcomes
1
Quantitative sensory testing
Responses to quantitative sensory tests that assess sensation of painful and non-painful stimuli. The stimuli are calibrated and carefully controlled with safety measures to prevent tissue damage.
Time frame
2-3 hours per measurement; measured several times from enrollment to last study visit for up to 16 weeks.2
Performance on Stair Climb Test
The stair climb test will assess how long it takes the participant to step fully up and down a single flight of stairs.
Time frame
5-10 minutes per measurement; measured several times from enrollment to last study visit for up to 16 weeks.3
Pain during physical function tasks
During standardized physical function tests, including a stair climb test, 4-meter walk test, balance test, and 30-second chair stand test, pain intensity will be reported. Pain intensity for each test is reported on the numeric rating scale (0-10) during this battery of tests.
Time frame
2-3 hours per measurement; measured several times from enrollment to last study visit for up to 16 weeks.4
Multidimensional pain assessment
Multidimensional aspects of chronic pain will be measured through written surveys.
Time frame
1 hour per measurement; measured several times from enrollment to last study visit for up to 16 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Benedict Alter
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
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