Status:
COMPLETED
Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Osteoarthritis, Knee
Chronic Pain
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
Brief Summary
Intra-articular injection of corticosteroid and hyaluronic acid is a common treatment for osteoarthritis of the knee. As a treatment drug for patients with depression, duloxetine has been shown in man...
Eligibility Criteria
Inclusion
- Participants meet American College of Rheumatology clinical and radiographic criteria for the diagnosis of knee osteoarthritis with knee pain \[ pain for ≥14 days of each month for ≥3 months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings before the trial\]
- Body mass index \< 40 kg/m2
- Radiographic criteria included Kellgren-Lawrence grade Ⅱ-III
- Knee stability, no deformity, no lumbar spondylosis with radiculopathy.
- Good cognition, and the ability to understand the study protocol and the agreement to participate.
Exclusion
- Inflammatory arthritis, autoimmune disorder, septic arthritis, or any other concomitant disease (such as liver and kidney disease)
- Those who prior synovial fluid analysis indicative of a diagnosis other than osteoarthritis
- Participants with contraindications to duloxetine (currently using monoamine oxidase inhibitors, poorly controlled angle-closure glaucoma), previous exposure to duloxetine, combined with other drugs acting on the central nervous system (such as benzodiazepines) and allergic to any of the medications used in this study.
- With metabolic diseases or anticoagulation therapy
- Participants who had received invasive treatments to the knee during the past 6 months; joint replacement of the knee at any time or current infection in the affected limb.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04117893
Start Date
October 1 2019
End Date
December 31 2021
Last Update
July 11 2023
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070