Physical ActivityPhase 4NCT03238183
Effects of Dextrose on Knee Osteoarthritis
A Phase 4 study testing dextrose and hyaluronic acid in people with Physical Activity and Functional Disturbance, 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 dextrose 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, Functional Disturbance
- What is being tested?
- dextrose and hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2017to Jul 2019
- 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
- knee osteoarthritis with Kellgren/Lawrence grade II or III
Who cannot join
- who have neurological deficit, such as stroke who have implant in knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Therapeutic Effects of Dextrose to Hyaluronic Acid 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 dextrose injection to patients with knee osteoarthritis.
Read the detailed description
A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.
The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.
The pain, physical activity, and functional performance will be evaluated.
All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six month after injection.
Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.
- Conditions
- Physical Activity, Functional Disturbance
- Being tested
- dextrose, hyaluronic acid
- Keywords
- knee osteoarthritis, hyaluronic acid, dextrose, therapeutic effects
- 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.
dextroseDrug
Also called glucose water
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
hyaluronic acidDevice
compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid combined dextrose group | Active comparator | Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections Receives: Drug: dextrose; Device: hyaluronic acid |
| hyaluronic acid group | Placebo comparator | Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections Receives: Device: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity-on level walking time
10 meter walking
Measured: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
physical activity-stair climbing time
stairs climbing
Measured: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
physical activity-chair rising time
chair rising
Measured: changes from baseline to at 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 to at one week after injection, one month after injection, three months after injection, and six month after injection
quality of life
Knee Injury and Osteoarthritis Outcome Score
Measured: changes from baseline to at 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 posted3 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
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 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
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238183
- Sponsor's protocol ID
- MOST 106-2314-B-341-003
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-Blind Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1505-1514. doi: 10.1016/j.apmr.2022.04.001. Epub 2022 Apr 16.
PubMed 35439521
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03238183
- Acronym / sponsor ID
- MOST 106-2314-B-341-003
- Conditions
- Physical Activity, Functional Disturbance
- Keywords
- knee osteoarthritis, hyaluronic acid, dextrose, therapeutic effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 3 Aug 2017 (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.
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 dextrose injection to patients with knee osteoarthritis.
Detailed description
A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.
The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.
The pain, physical activity, and functional performance will be evaluated.
All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six month after injection.
Subjects and the evaluator will be both blinded to the group's classification during the whole course of study.
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 combined dextrose group | Active comparator | Drug: dextrose, Device: hyaluronic acidHyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections |
| hyaluronic acid group | Placebo comparator | Device: hyaluronic acidHyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee osteoarthritis with Kellgren/Lawrence grade II or III
Key exclusion criteria (1 listed)
- who have neurological deficit, such as stroke who have implant in knee
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 |
|---|---|---|
| dextroseAlso: glucose watercompare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis | Drug | hyaluronic acid combined dextrose group |
| hyaluronic acidcompare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis | Device | hyaluronic acid combined dextrose group, hyaluronic acid group |
Primary outcome
physical activity-on level walking time
Time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
10 meter walking
physical activity-stair climbing time
Time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
stairs climbing
physical activity-chair rising time
Time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
chair rising
2 secondary outcomes
functional performance
Time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
quality of life
Time frame: changes from baseline to at 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 3 Aug 2017.
- Derived from this study: PubMed 35439521Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-Blind Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1505-1514. doi: 10.1016/j.apmr.2022.04.001. Epub 2022 Apr 16.
- 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.
Ru-Lan Hsieh principal investigator
Shin Kong Wu Ho-Su Memorial 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 dextrose and hyaluronic acid in people with Physical Activity and Functional Disturbance, 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 1 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 3 Aug 2017. 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. 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 Ru-Lan Hsieh (228332211, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity-on level walking time (time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month 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?
On the ClinicalTrials.gov record for NCT03238183, 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 3 Aug 2017.