Arthritis KneeNCT06301958
Dextrose Prolotherapy on Articular Cartilage
A study testing Dextrose prolotherapy in people with Arthritis Knee, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Dextrose prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2023to 31 Aug 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign a written consent form
- Adult men and women with arthritis
Who cannot join
- Pregnant or lactating women
- Septic arthritis
- Those who have undergone joint surgery within 30 days
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Chiayi
Chiayi City, 嘉義市, 600
HUNG-CHIH HSU, PhD, +886-3-3621000 ext. 2601, dr.tonyhsu@gmail.com
About this study
Official title: The Effects and Molecular Mechanisms of Dextrose Prolotherapy on Articular Cartilage
Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.
We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.
- Conditions
- Arthritis Knee
- Being tested
- Dextrose prolotherapy
- Keywords
- Dextrose, Prolotherapy, Joint Pain, Synovial Fluid
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose prolotherapyDrug
Also called Regenerative injection therapy
A 25% dextrose solution is used to relieve arthritis of the knee joint like osteoarthritis and rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose prolotherapy | Experimental | A subject received a single intra-articular injection of 25% hypertonic glucose solution 10 mL (1:1 of 50% dextrose and normal saline) into one knee with arthritis after aspiration of all synovial fluid. Receives: Drug: Dextrose prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Measurement of knee pain
Measured: baseline, 1 month after treatment, and 3 months after treatment
Secondary outcomes (2)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Osteoarthritis Index
Measured: baseline, 1 month after treatment, and 3 months after treatment
Interleukin 6 (IL-6)
An inflammation-related biomarker
Measured: baseline, 1 month after treatment, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start21 Jan 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSU, HUNG-CHIH, Chang Gung Memorial Hospital
- Investigators
- Hung-Chih Hsu, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301958
- Sponsor's protocol ID
- 202102567A3
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing upon request
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Molecular Mechanisms of Dextrose Prolotherapy on Articular Cartilage
- ClinicalTrials.gov ID
- NCT06301958
- Acronym / sponsor ID
- 202102567A3
- Conditions
- Arthritis Knee
- Keywords
- Dextrose, Prolotherapy, Joint Pain, Synovial Fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 Mar 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.
Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid.
We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dextrose prolotherapy | Experimental | Drug: Dextrose prolotherapyA subject received a single intra-articular injection of 25% hypertonic glucose solution 10 mL (1:1 of 50% dextrose and normal saline) into one knee with arthritis after aspiration of all synovial fluid. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to sign a written consent form
- Adult men and women with arthritis
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Septic arthritis
- Those who have undergone joint surgery within 30 days
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 |
|---|---|---|
| Dextrose prolotherapyAlso: Regenerative injection therapyA 25% dextrose solution is used to relieve arthritis of the knee joint like osteoarthritis and rheumatoid arthritis. | Drug | Dextrose prolotherapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: baseline, 1 month after treatment, and 3 months after treatment
Measurement of knee pain
2 secondary outcomes
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: baseline, 1 month after treatment, and 3 months after treatment
Interleukin 6 (IL-6)
Time frame: baseline, 1 month after treatment, and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No. IPD sharing upon request
Related trials for Arthritis Knee
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Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
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SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
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Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
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.
Hung-Chih Hsu, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose prolotherapy in people with Arthritis Knee, run by Chang Gung Memorial Hospital 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 2 inclusion and 3 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 8 Mar 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 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 Hung-Chih Hsu, PhD (+886-3-3621000 ext. 2601, dr.tonyhsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: baseline, 1 month after treatment, and 3 months after treatment). 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 8 Mar 2024.