Osteoarthritis, KneeNCT03400631
Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis
A study testing Dextrose 0, Aspiration 0 and Dextrose 1 in people with Osteoarthritis, Knee, run by Fisiatria y Traumatología at 1 site in Argentina.
Trial summary
Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Dextrose 0, Aspiration 0 and Dextrose 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2018to 23 Nov 2021
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain for at least 6 months.
- Clinically diagnosed knee osteoarthritis.
- Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
- Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.
Who cannot join
- Anticoagulation therapy.
- Inflammatory or post-infectious knee arthritis.
- Systemic inflammatory conditions.
- Knee flexion of less than 100 degrees.
- Knee extension of less than 165 degrees.
- Any Valgus
Show all 11Show fewer
- Varus more than 15 degrees.
- Any knee injection in the past 3 months.
- BMI more than 40
- Gross synovial folds on ultrasound
- Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Gaston Topol, M.D.. Private Office
Rosario, Santa Fe Province, CS2000CXP
About this study
Official title: Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis
Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .
Read the detailed description
Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.
At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.
At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.
After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Dextrose 0, Aspiration 0, Dextrose 1, Aspiration 1
- Keywords
- Cytokine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 0Drug
Dextrose injection at time 0
Aspiration 0Drug
Aspiration only at time 0
Dextrose 1Drug
Dextrose injection at week 1
Aspiration 1Drug
Aspiration only at week 1
| Study group | Role | What they receive |
|---|---|---|
| Dextrose 0. Aspiration 1 week. | Experimental | Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. Receives: Drug: Dextrose 0; Drug: Aspiration 1 |
| Aspiration 0. Dextrose 1 week. | Experimental | Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. Receives: Drug: Aspiration 0; Drug: Dextrose 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term change in cytokine levels
Change in cytokine levels from baseline to 1 week
Measured: Obtained at baseline and 1 week
Long term change in cytokine levels
Change in cytokine levels from baseline to 3 months
Measured: Obtained at baseline and 3 months
Secondary outcomes (2)
Post Injection Short Term Pain Course
Numerical rating scale (NRS) 0-10 pain score measured after time 0 and 1 week injections
Measured: 0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections
WOMAC score
Western Ontario and McMaster Universities Arthritis Index normalized to 100
Measured: Obtained at baseline, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Aug 2018
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first two weeks of this study involve two groups with a crossover at 1 week. From two weeks on, there is a single arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisiatria y Traumatología
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Orthopaedic Medicine
- Responsible party
- Principal investigator, Gaston Andres Topol, Fisiatria y Traumatología
- Investigators
- Gaston Topol, M.D., Principal investigator, University of Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400631
- Sponsor's protocol ID
- AAFOYT
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2017
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be available by request.
Publications
Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY. Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016 May 5;6:25247. doi: 10.1038/srep25247.
PubMed 27146849Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamin A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4.
PubMed 27058744
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03400631
- Acronym / sponsor ID
- AAFOYT
- Conditions
- Osteoarthritis, Knee
- Keywords
- Cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fisiatria y TraumatologíaUniversity, hospital or other
- Collaborators
- American Association of Orthopaedic Medicine
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 17 Jan 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.
Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .
Detailed description
Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.
At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.
At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.
After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The first two weeks of this study involve two groups with a crossover at 1 week. From two weeks on, there is a single arm.
| Arm | Type | Receives |
|---|---|---|
| Dextrose 0. Aspiration 1 week. | Experimental | Drug: Dextrose 0, Drug: Aspiration 1Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. |
| Aspiration 0. Dextrose 1 week. | Experimental | Drug: Aspiration 0, Drug: Dextrose 1Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee pain for at least 6 months.
- Clinically diagnosed knee osteoarthritis.
- Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
- Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.
Key exclusion criteria (11 listed)
- Anticoagulation therapy.
- Inflammatory or post-infectious knee arthritis.
- Systemic inflammatory conditions.
- Knee flexion of less than 100 degrees.
- Knee extension of less than 165 degrees.
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 0Dextrose injection at time 0 | Drug | Dextrose 0. Aspiration 1 week. |
| Aspiration 0Aspiration only at time 0 | Drug | Aspiration 0. Dextrose 1 week. |
| Dextrose 1Dextrose injection at week 1 | Drug | Aspiration 0. Dextrose 1 week. |
| Aspiration 1Aspiration only at week 1 | Drug | Dextrose 0. Aspiration 1 week. |
Primary outcome
Short term change in cytokine levels
Time frame: Obtained at baseline and 1 week
Change in cytokine levels from baseline to 1 week
Long term change in cytokine levels
Time frame: Obtained at baseline and 3 months
Change in cytokine levels from baseline to 3 months
2 secondary outcomes
Post Injection Short Term Pain Course
Time frame: 0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections
WOMAC score
Time frame: Obtained at baseline, 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 27146849Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY. Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016 May 5;6:25247. doi: 10.1038/srep25247.
- Background: PubMed 27058744Topol GA, Podesta LA, Reeves KD, Giraldo MM, Johnson LL, Grasso R, Jamin A, Clark T, Rabago D. Chondrogenic Effect of Intra-articular Hypertonic-Dextrose (Prolotherapy) in Severe Knee Osteoarthritis. PM R. 2016 Nov;8(11):1072-1082. doi: 10.1016/j.pmrj.2016.03.008. Epub 2016 Apr 4.
- Individual participant dataSharing planned: Undecided. This will be available by request.
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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.
Gaston Topol, M.D. principal investigator
University of Argentina
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 0, Aspiration 0 and Dextrose 1 in people with Osteoarthritis, Knee, run by Fisiatria y Traumatología at 1 site in Argentina.
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 11 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: finished, as of the sponsor's last update on 11 Aug 2022. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short term change in cytokine levels (time frame: Obtained at baseline and 1 week). The study lists 2 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 NCT03400631, which also lists 2 linked publications.
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 Aug 2022.