Osteoarthritis, KneePhase 4NCT04117893
Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
A Phase 4 study testing Duloxetine and intra-articular injection of corticosteroid and hyaluronic acid in people with Osteoarthritis, Knee and Chronic Pain, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Chronic Pain
- What is being tested?
- Duloxetine and intra-articular injection of corticosteroid and hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoarthritis, Knee, Chronic Pain
- Being tested
- Duloxetine, intra-articular injection of corticosteroid and hyaluronic acid
- Keywords
- Osteoarthritis, Knee, Chronic Pain, hyaluronic acid, corticosteroid, duloxetine, Intra-articular injection
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.
intra-articular injection of corticosteroid and hyaluronic acidDrug
Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine combined with intra-articular injection | Experimental | Not described Receives: Drug: Duloxetine; Drug: intra-articular injection of corticosteroid and hyaluronic acid |
| Intra-articular injection | Active comparator | Not described Receives: Drug: intra-articular injection of corticosteroid and hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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')
Measured: Twenty-fourth weeks
Secondary outcomes (5)
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.
Measured: At weeks 1, 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.
Measured: At weeks 1, 2, 4, 8, 16 and 24 post-injection
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.
Measured: At weeks 1, 2, 4, 8, 16 and 24 post-injection
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.
Measured: At weeks 2, 4, 8, 16 and 24 post-injection
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.
Measured: At weeks 2, 4, 8, 16 and 24 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117893
- Sponsor's protocol ID
- KY 2019-086-02
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2019
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article will be shared after deidentification.
Publications
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.
PubMed 33109641
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04117893
- Acronym / sponsor ID
- KY 2019-086-02
- Conditions
- Osteoarthritis, Knee, Chronic Pain
- Keywords
- Osteoarthritis, Knee, Chronic Pain, hyaluronic acid, corticosteroid, duloxetine, Intra-articular injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine combined with intra-articular injection | Experimental | Drug: Duloxetine, Drug: intra-articular injection of corticosteroid and hyaluronic acid |
| Intra-articular injection | Active comparator | Drug: intra-articular injection of corticosteroid and hyaluronic acid |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineParticipants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks. | Drug | Duloxetine combined with intra-articular injection |
| intra-articular injection of corticosteroid and hyaluronic acidParticipants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide. | Drug | Duloxetine combined with intra-articular injection, Intra-articular injection |
Primary outcome
Weekly mean of the 24h average pain scores
Time frame: Twenty-fourth weeks
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')
5 secondary outcomes
The response to treatment
Time frame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
The Brief Pain Inventory
Time frame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: At weeks 1, 2, 4, 8, 16 and 24 post-injection
The Patient Global Impression of Improvement Scale
Time frame: At weeks 2, 4, 8, 16 and 24 post-injection
Hospital Anxiety and Depression Scale
Time frame: At weeks 2, 4, 8, 16 and 24 post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 33109641Li 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article will be shared after deidentification.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Luo, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine and intra-articular injection of corticosteroid and hyaluronic acid in people with Osteoarthritis, Knee and Chronic Pain, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly mean of the 24h average pain scores (time frame: Twenty-fourth weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.