Knee OsteoarthritisPhase 4NCT06279507
Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
A Phase 4 study testing Sodium Hyaluronate, Normal Saline and Triamcinolone Acetonide 10mg/mL in people with Knee Osteoarthritis and Pain, Joint, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are: Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis Is Hyaluronic… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain, Joint, Stiffness of Knee, Not Elsewhere Classified
- What is being tested?
- Sodium Hyaluronate, Normal Saline and Triamcinolone Acetonide 10mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteThailand
- Study dates
- 10 Feb 2024to 30 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
- Pain visual analog scare of 4 or higher
Who cannot join
- Cognitive impairment
- History of aller to Hyaluronic acid or its component
- History of knee arthropathy
- Concomitant with inflammatory arthritis
- Serious comorbidities or bedridden status
- Current pregnancy or lactation
- Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA)
- Communication problem
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Hospital
Bangkok, 10400
Suthee Panichkul, 6623547600 ext. 93681, suthee99@yahoo.com
About this study
Official title: The Efficacy of Hyaluronic Acid Injection as an Adjunctive Treatment After Intraarticular Low-dose Glucocorticoid Injection for Symptomatic Knee Osteoarthritis: A Multicenter Randomized, Controlled, Double-blinded Study
The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:
- Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
- Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis
Read more
Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.
Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.
Read the detailed description
Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.
Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.
- Conditions
- Knee Osteoarthritis, Pain, Joint, Stiffness of Knee, Not Elsewhere Classified, Quality of Life
- Being tested
- Sodium Hyaluronate, Normal Saline, Triamcinolone Acetonide 10mg/mL
- Keywords
- Hyaluronic acid, Adjunctive treatment
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Also called Ostenil Plus
Sodium hyaluronate 2% (40 mg/2 mL), with molecular weight of 1-2 million dalton Other active ingredient : Mannitol 0.5% Preparation : Pre-filled syringe
Normal SalineDrug
Also called 0.9% sodium chloride
0.9% sodium chloride 2 mL prepared in plastic syringe
Triamcinolone Acetonide 10mg/mLDrug
10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Active comparator | Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection Receives: Drug: Sodium Hyaluronate; Drug: Triamcinolone Acetonide 10mg/mL |
| Normal saline | Placebo comparator | Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection Receives: Drug: Normal Saline; Drug: Triamcinolone Acetonide 10mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain outcome measurement
The comparison between Hyaluronic acid and normal saline injection in the change of joint pain after the injection, by using visual analog scale and pain domain assessment in Western Ontario and McMaster University (WOMAC) scale (scale 0-10, which higher scale reflects worse symptom)
Measured: 12 and 24 weeks after injection
Joint stiffness and function measurement
The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function)
Measured: 12 and 24 weeks after injection
Overall symptom assessment
The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition)
Measured: 12 and 24 weeks after injection
Secondary outcomes (2)
Knee performance evaluation
The comparison between Hyaluronic acid and normal saline injection in the change of knee performance status after the injection, assessed by Time Up and Go test
Measured: 12 and 24 weeks after injection
Quality of life assessment
The comparison between Hyaluronic acid and normal saline injection in the change of health-related quality of life assessed by EuroQol group - 5 Dimensions - 5 Levels (EQ-5D-5L) tool (scale 0-100, which higher scale reflects better health)
Measured: 12 and 24 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Feb 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Model description
- The participants would be allocated into one treatment group; * Intervention group : Hyaluronic acid injection * Placebo group : Normal saline
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University, Police General Hospital
- Responsible party
- Sponsor
- Investigators
- Nis Okuma, Medical, Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279507
- Sponsor's protocol ID
- PMK-00007
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hyaluronic Acid Injection as an Adjunctive Treatment After Intraarticular Low-dose Glucocorticoid Injection for Symptomatic Knee Osteoarthritis: A Multicenter Randomized, Controlled, Double-blinded Study
- ClinicalTrials.gov ID
- NCT06279507
- Acronym / sponsor ID
- PMK-00007
- Conditions
- Knee Osteoarthritis, Pain, Joint, Stiffness of Knee, Not Elsewhere Classified, Quality of Life
- Keywords
- Hyaluronic acid, Adjunctive treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Khon Kaen University, Police General Hospital
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:
- Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
- Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis
Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.
Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.
Detailed description
Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.
Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants would be allocated into one treatment group; * Intervention group : Hyaluronic acid injection * Placebo group : Normal saline
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Active comparator | Drug: Sodium Hyaluronate, Drug: Triamcinolone Acetonide 10mg/mLHyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection |
| Normal saline | Placebo comparator | Drug: Normal Saline, Drug: Triamcinolone Acetonide 10mg/mLTwo-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
- Pain visual analog scare of 4 or higher
Key exclusion criteria (8 listed)
- Cognitive impairment
- History of aller to Hyaluronic acid or its component
- History of knee arthropathy
- Concomitant with inflammatory arthritis
- Serious comorbidities or bedridden status
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 |
|---|---|---|
| Sodium HyaluronateAlso: Ostenil PlusSodium hyaluronate 2% (40 mg/2 mL), with molecular weight of 1-2 million dalton Other active ingredient : Mannitol 0.5% Preparation : Pre-filled syringe | Drug | Hyaluronic acid |
| Normal SalineAlso: 0.9% sodium chloride0.9% sodium chloride 2 mL prepared in plastic syringe | Drug | Normal saline |
| Triamcinolone Acetonide 10mg/mL10 mg of triamcinolone acetonide will be injected to all participants before the specified intervention | Drug | Hyaluronic acid, Normal saline |
Primary outcome
Pain outcome measurement
Time frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of joint pain after the injection, by using visual analog scale and pain domain assessment in Western Ontario and McMaster University (WOMAC) scale (scale 0-10, which higher scale reflects worse symptom)
Joint stiffness and function measurement
Time frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function)
Overall symptom assessment
Time frame: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition)
2 secondary outcomes
Knee performance evaluation
Time frame: 12 and 24 weeks after injection
Quality of life assessment
Time frame: 12 and 24 weeks after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Nis Okuma, Medical principal investigator
Phramongkutklao College of Medicine and 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 Sodium Hyaluronate, Normal Saline and Triamcinolone Acetonide 10mg/mL in people with Knee Osteoarthritis and Pain, Joint, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nis Okuma, Medical (669-24759900, nitzumo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain outcome measurement (time frame: 12 and 24 weeks after injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.