Clinical trial NCT04117893: Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Official title: Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Chronic Pain
Keywords: Osteoarthritis, Knee
Chronic Pain
hyaluronic acid
corticosteroid
duloxetine
Intra-articular injection
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 many studies to effectively relieve the pain of osteoarthritis and improve the function of the knee joint. However, there is no evidence regarding the efficacy of Intra-articular injection of corticosteroid and hyaluronic acid combined with duloxetine for pain management in patients with knee osteoarthritis. The aim of the study was to test the hypothesis that Intra-articular injection of corticosteroid plus hyaluronic acid combined with duloxetine could achieve superior pain management effects to Intra-articular injection of corticosteroid plus hyaluronic acid alone in patients undergoing knee osteoarthritis pain.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Weekly mean of the 24h average pain scores
timeFrame: Twenty-fourth weeks
Secondary outcomes:
measure: The response to treatment
timeFrame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
measure: The Brief Pain Inventory
timeFrame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
measure: The Patient Global Impression of Improvement Scale
timeFrame: At weeks 2, 4, 8, 16 and 24 post-injection
measure: Hospital Anxiety and Depression Scale
timeFrame: At weeks 2, 4, 8, 16 and 24 post-injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li DY, Han R, Zhao ZG, Luo F. Duloxetine combined with intra-articular injection versus intra-articular injection alone for pain relief in knee osteoarthritis: a study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 27;10(10):e036447. doi: 10.1136/bmjopen-2019-036447.