Osteoarthritis, KneeNCT02888795
Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array
A study testing hypertonic dextrose prolotherapy in people with Osteoarthritis, Knee, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
Trial summary
Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a long time. However the study about the mechanism is scant. The question of biomarkers of knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- hypertonic dextrose prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2016to 26 May 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- at least 6 months of symptomatic knee OA
- clinical criteria of moderate or moderate to severe knee OA ( the American Rheumatological Association grade II or III)
Who cannot join
- severe knee OA (grade IV)
- rheumatoid or other inflammatory arthritis
- received physiotherapy, oral NSAIDs, corticosteroids or anticoagulant, during previous 2 weeks prior the treatment
- received any knee intra-articular injections during previous one month prior the treatment
- poorly controlled diabetes mellitus with fasting blood sugar greater than 200 mg/dL-
- history of knee surgery
- dementia or psychological disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine & Rehabiliation, National Yang-Ming University Hospital
Yilan, 26042
About this study
Official title: Identification of Early Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by an Inflammation-related Cytokine Array
Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a long time. However the study about the mechanism is scant. The question of biomarkers of knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On this basis, the aim of this study was to characterize the secreted protein factors behind the inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.
10~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of inflammatory factors will be measured by a novel cytokine antibody array methodology. The study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid. Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array membranes incubated with tissue lysates will quantitatively depict as a histogram for relative cytokine induction or reduction in the synovial fluid. The cytokines messenger ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and after interventions will be compared. Differences between groups will be determined by the Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF isoforms pattern will be determined with the Spearman correlation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- hypertonic dextrose prolotherapy
- Keywords
- hypertonic dextrose prolotherapy, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic dextrose prolotherapyDrug
five intra-articular injection at 2-weeks intervals in weeks 0, 2, 4, 6, 8.
| Study group | Role | What they receive |
|---|---|---|
| hypertonic dextrose prolotherapy | Experimental | Not described Receives: Drug: hypertonic dextrose prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario McMaster University Osteoarthritis Index
Measured: change from baseline at week 10
Secondary outcomes (2)
standing knee X ray posterior-anterior view
the minimum joint space width (mJSW) of the medial and lateral compartment respectively of the tibio-femoral joint
Measured: change from baseline at week 10
protein array method for inflammatory factors
Human Angiogenesis Antibody Array
Measured: change from baseline at week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start19 Feb 2016
- Primary completion26 May 2017
- Study completion26 May 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888795
- Sponsor's protocol ID
- RD2016-018
- Status last verified
- Dec 2018
- First submitted
- 24 Aug 2016
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: not all patients agreed to share primary data to person not related to study
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by an Inflammation-related Cytokine Array
- ClinicalTrials.gov ID
- NCT02888795
- Acronym / sponsor ID
- RD2016-018
- Conditions
- Osteoarthritis, Knee
- Keywords
- hypertonic dextrose prolotherapy, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 5 Sep 2016 (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.
Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a long time. However the study about the mechanism is scant. The question of biomarkers of knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On this basis, the aim of this study was to characterize the secreted protein factors behind the inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.
10~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of inflammatory factors will be measured by a novel cytokine antibody array methodology. The study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid. Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array membranes incubated with tissue lysates will quantitatively depict as a histogram for relative cytokine induction or reduction in the synovial fluid. The cytokines messenger ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and after interventions will be compared. Differences between groups will be determined by the Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF isoforms pattern will be determined with the Spearman correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypertonic dextrose prolotherapy | Experimental | Drug: hypertonic dextrose prolotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- at least 6 months of symptomatic knee OA
- clinical criteria of moderate or moderate to severe knee OA ( the American Rheumatological Association grade II or III)
Key exclusion criteria (7 listed)
- severe knee OA (grade IV)
- rheumatoid or other inflammatory arthritis
- received physiotherapy, oral NSAIDs, corticosteroids or anticoagulant, during previous 2 weeks prior the treatment
- received any knee intra-articular injections during previous one month prior the treatment
- poorly controlled diabetes mellitus with fasting blood sugar greater than 200 mg/dL-
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 |
|---|---|---|
| hypertonic dextrose prolotherapyfive intra-articular injection at 2-weeks intervals in weeks 0, 2, 4, 6, 8. | Drug | hypertonic dextrose prolotherapy |
Primary outcome
Western Ontario McMaster University Osteoarthritis Index
Time frame: change from baseline at week 10
2 secondary outcomes
standing knee X ray posterior-anterior view
Time frame: change from baseline at week 10
protein array method for inflammatory factors
Time frame: change from baseline at week 10
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 31 Dec 2018.
- Individual participant dataSharing planned: No. not all patients agreed to share primary data to person not related to study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypertonic dextrose prolotherapy in people with Osteoarthritis, Knee, run by National Yang Ming Chiao Tung University 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 7 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 31 Dec 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?
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?
Western Ontario McMaster University Osteoarthritis Index (time frame: change from baseline at week 10). 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 31 Dec 2018.