Osteoarthritis, KneeNCT03690232
Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
A study testing glucose water and hyaluronic aicd in people with Osteoarthritis, Knee, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- glucose water and hyaluronic aicd
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Oct 2018to 1 Jun 2020
- Phase
- Interventional
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people aged 45 years or more;
- subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
- subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
- subjects with tenderness in the medial tibial plateau area
Who cannot join
- . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
- . Inflammatory arthritis or subjects with acute knee arthritis
- . subjects who have received intraarticular injection on the affected knee within the past 3 months.
- . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 241
Jia chi c Wang, MD, 886-2-28757361, jcwang0726@gmail.com
About this study
Official title: Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
Read the detailed description
The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment
- Conditions
- Osteoarthritis, Knee
- Being tested
- glucose water, hyaluronic aicd
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose waterDrug
3 sessions of 6cc 25% glucose injection with a 2-week interval
hyaluronic aicdDrug
Also called Hyruan
intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment
| Study group | Role | What they receive |
|---|---|---|
| Glucose group | Experimental | The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment Receives: Drug: glucose water |
| hyaluronic acid group | Active comparator | The HA group was administered intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. Receives: Drug: hyaluronic aicd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
Measured: 12 weeks
Secondary outcomes (2)
Lequesne index
The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living
Measured: 0,6,12 weeks
visual analogue scale (VAS)
pain intensity was measured by VAS from 0 to 10
Measured: 0,6,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start8 Oct 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jia chi Wang, MD, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690232
- Sponsor's protocol ID
- 2018-01-014C
- Status last verified
- Oct 2018
- First submitted
- 9 Sep 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
- ClinicalTrials.gov ID
- NCT03690232
- Acronym / sponsor ID
- 2018-01-014C
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 1 Oct 2018 (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 study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
Detailed description
The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.
| Arm | Type | Receives |
|---|---|---|
| Glucose group | Experimental | Drug: glucose waterThe glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment |
| hyaluronic acid group | Active comparator | Drug: hyaluronic aicdThe HA group was administered intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- people aged 45 years or more;
- subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology
- subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
- subjects with tenderness in the medial tibial plateau area
Key exclusion criteria (4 listed)
- . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;
- . Inflammatory arthritis or subjects with acute knee arthritis
- . subjects who have received intraarticular injection on the affected knee within the past 3 months.
- . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.
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 |
|---|---|---|
| glucose water3 sessions of 6cc 25% glucose injection with a 2-week interval | Drug | Glucose group |
| hyaluronic aicdAlso: Hyruanintra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment | Drug | hyaluronic acid group |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
2 secondary outcomes
Lequesne index
Time frame: 0,6,12 weeks
visual analogue scale (VAS)
Time frame: 0,6,12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- 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.
Jia chi Wang, MD study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose water and hyaluronic aicd in people with Osteoarthritis, Knee, run by Taipei Veterans General Hospital, Taiwan 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 4 inclusion and 4 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 11 Oct 2018. 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.
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 Jia chi Wang, MD (886-2-28757361, jcwang0726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 12 weeks). 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 11 Oct 2018.