Physical ActivityPhase 4NCT02625727
Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
A Phase 4 study testing hyaluronic acid and hyaluronic acid combined corticosteroid in people with Physical Activity, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- hyaluronic acid and hyaluronic acid combined corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Jul 2016
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Osteoarthritis of knee with Kellgren/Lawrence grade II or III
Who cannot join
- Who have implant in knee
- History of neurological deficit, such as stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.
Read the detailed description
A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.
Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.
Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.
- Conditions
- Physical Activity
- Being tested
- hyaluronic acid, hyaluronic acid combined corticosteroid
- Keywords
- knee osteoarthritis, hyaluronic acid, corticosteroid, intra-articular injection, therapeutic effect
- Medical subject headings
- Motor Activity, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acidOther
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
hyaluronic acid combined corticosteroidOther
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid group | Experimental | hyaluronic acid injection Receives: Other: hyaluronic acid |
| hyaluronic acid and corticosteroid group | Active comparator | hyaluronic acid combined corticosteroid injection Receives: Other: hyaluronic acid combined corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
Measured: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
Secondary outcomes (2)
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
Measured: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
functional performance (Knee injury and Osteoarthritis Outcome Score)
Measured: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625727
- Sponsor's protocol ID
- MOST104-2314-B-341-001
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02625727
- Acronym / sponsor ID
- MOST104-2314-B-341-001
- Conditions
- Physical Activity
- Keywords
- knee osteoarthritis, hyaluronic acid, corticosteroid, intra-articular injection, therapeutic effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- 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.
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.
Detailed description
A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.
Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.
Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid group | Experimental | Other: hyaluronic acidhyaluronic acid injection |
| hyaluronic acid and corticosteroid group | Active comparator | Other: hyaluronic acid combined corticosteroidhyaluronic acid combined corticosteroid injection |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of knee with Kellgren/Lawrence grade II or III
Key exclusion criteria (2 listed)
- Who have implant in knee
- History of neurological deficit, such as stroke
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 |
|---|---|---|
| hyaluronic acidcompare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis | Other | hyaluronic acid group |
| hyaluronic acid combined corticosteroidcompare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis | Other | hyaluronic acid and corticosteroid group |
Primary outcome
physical activity
Time frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
2 secondary outcomes
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
Time frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
functional performance (Knee injury and Osteoarthritis Outcome Score)
Time frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
Ru-Lan Hsieh, MD principal investigator
associate professor
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 hyaluronic acid and hyaluronic acid combined corticosteroid in people with Physical Activity, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 2 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 9 Dec 2015. 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 Taiwan. 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?
Results are not available in the source record.
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?
physical activity (time frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection). 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 9 Dec 2015.