Back to resultsDuloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Primary Purpose
Osteoarthritis, Knee, Chronic Pain
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Duloxetine
intra-articular injection of corticosteroid and hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Chronic Pain, hyaluronic acid, corticosteroid, duloxetine, Intra-articular injection
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.
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Duloxetine combined with intra-articular injection
Intra-articular injection
Arm Description
Outcomes
Primary Outcome Measures
Weekly mean of the 24h average pain scores
Weekly mean of the 24h average pain scores in participants with osteoarthritis knee pain at the end of 24 weeks as reported in participants' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')
Secondary Outcome Measures
The response to treatment
The response to treatment defines as a 30% and a 50% reduction of weekly mean score in 24-h average pain severity ratings from baseline to endpoint at weeks1,2,4,8,16 and 24 post-injection.
The Brief Pain Inventory
This is a self-reported scale that will use to measure the severity of pain and the interference of pain on function at weeks 1, 2, 4, 8, 16 and 24 post-injection. The severity of the pain was assessed by four questions: participants were rated on their most severe pain, their least severe pain, their average pain over the past 24 hours, and their current pain. The pain scale range from 0(no pain) to 10（extreme pain）. In the past 24 hours, seven questions assessed the impact of pain on daily activities, mood, walking ability, working normally, relationships with others, sleep and pleasure in life. The interference level ranges from 0(no interference) to 10(complete interference), and the average of the interference terms is obtained as a summary interference measurement.
The Western Ontario and McMaster Universities Osteoarthritis Index
This instrument is designed to assess pain, stiffness, and physical function in participants with osteoarthritis of the knee and will be evaluate at weeks 1, 2, 4, 8, 16 and 24 post-injection. It consists of 24 questions: 5 on pain, 2 on stiffness, and 17 on physical function, each answered using a 5-point scale ranging from 0 (none) to 4 (extreme). Higher scores on the Western Ontario and McMaster Universities Osteoarthritis Index indicate worse pain, stiffness and functional limitations.
The Patient Global Impression of Improvement Scale
A patient-rated 7-point scale of symptomatic improvement, was assessed at all visits starting 2 weeks after treatment. On the The Patient Global Impression of Improvement Scale, a rating of 1 indicates that the participant is 'very much improved', a rating of 4 indicates that the participant has experienced 'no change', and a rating of 7 indicates that the participant is 'very much worse'. which range from 1 to 7.
Hospital Anxiety and Depression Scale
This self-rating patient-reported outcome measure will be developed to assess depression and anxiety in patients. Responses are rated on a 4-point Likert scale and range from 0 to 3, with higher scores indicating higher severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04117893
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Chronic Pain
Keywords
Osteoarthritis, Knee, Chronic Pain, hyaluronic acid, corticosteroid, duloxetine, Intra-articular injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
This is a prospective, randomized, open-label blind endpoint (PROBE) study
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine combined with intra-articular injection
Arm Type
Experimental
Arm Title
Intra-articular injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.
Intervention Type
Drug
Intervention Name(s)
intra-articular injection of corticosteroid and hyaluronic acid
Intervention Description
Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.
Primary Outcome Measure Information:
Title
Weekly mean of the 24h average pain scores
Description
Weekly mean of the 24h average pain scores in participants with osteoarthritis knee pain at the end of 24 weeks as reported in participants' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')
Time Frame
Twenty-fourth weeks
Secondary Outcome Measure Information:
Title
The response to treatment
Description
The response to treatment defines as a 30% and a 50% reduction of weekly mean score in 24-h average pain severity ratings from baseline to endpoint at weeks1,2,4,8,16 and 24 post-injection.
Time Frame
At weeks 1, 2, 4, 8, 16 and 24 post-injection
Title
The Brief Pain Inventory
Description
This is a self-reported scale that will use to measure the severity of pain and the interference of pain on function at weeks 1, 2, 4, 8, 16 and 24 post-injection. The severity of the pain was assessed by four questions: participants were rated on their most severe pain, their least severe pain, their average pain over the past 24 hours, and their current pain. The pain scale range from 0(no pain) to 10（extreme pain）. In the past 24 hours, seven questions assessed the impact of pain on daily activities, mood, walking ability, working normally, relationships with others, sleep and pleasure in life. The interference level ranges from 0(no interference) to 10(complete interference), and the average of the interference terms is obtained as a summary interference measurement.
Time Frame
At weeks 1, 2, 4, 8, 16 and 24 post-injection
Title
The Western Ontario and McMaster Universities Osteoarthritis Index
Description
This instrument is designed to assess pain, stiffness, and physical function in participants with osteoarthritis of the knee and will be evaluate at weeks 1, 2, 4, 8, 16 and 24 post-injection. It consists of 24 questions: 5 on pain, 2 on stiffness, and 17 on physical function, each answered using a 5-point scale ranging from 0 (none) to 4 (extreme). Higher scores on the Western Ontario and McMaster Universities Osteoarthritis Index indicate worse pain, stiffness and functional limitations.
Time Frame
At weeks 1, 2, 4, 8, 16 and 24 post-injection
Title
The Patient Global Impression of Improvement Scale
Description
A patient-rated 7-point scale of symptomatic improvement, was assessed at all visits starting 2 weeks after treatment. On the The Patient Global Impression of Improvement Scale, a rating of 1 indicates that the participant is 'very much improved', a rating of 4 indicates that the participant has experienced 'no change', and a rating of 7 indicates that the participant is 'very much worse'. which range from 1 to 7.
Time Frame
At weeks 2, 4, 8, 16 and 24 post-injection
Title
Hospital Anxiety and Depression Scale
Description
This self-rating patient-reported outcome measure will be developed to assess depression and anxiety in patients. Responses are rated on a 4-point Likert scale and range from 0 to 3, with higher scores indicating higher severity.
Time Frame
At weeks 2, 4, 8, 16 and 24 post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article will be shared after deidentification.
IPD Sharing Time Frame
The date will be shared from 6 months to 5 years following article publication.
IPD Sharing Access Criteria
An independent review committee will be responsible for reviewing applications and purposes from investigators. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request once the study has been completed.
Citations:
PubMed Identifier
33109641
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.
Results Reference
derived
Learn more about this trial
Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
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