Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hypertonic dextrose prolotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring hypertonic dextrose prolotherapy, osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Physical Medicine & Rehabiliation, National Yang-Ming University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hypertonic dextrose prolotherapy
Arm Description
Outcomes
Primary Outcome Measures
Western Ontario McMaster University Osteoarthritis Index
Secondary Outcome Measures
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
protein array method for inflammatory factors
Human Angiogenesis Antibody Array
Full Information
NCT ID
NCT02888795
First Posted
August 24, 2016
Last Updated
December 28, 2018
Sponsor
National Yang Ming Chiao Tung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02888795
Brief Title
Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array
Official Title
Identification of Early Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by an Inflammation-related Cytokine Array
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
May 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming Chiao Tung University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
hypertonic dextrose prolotherapy, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypertonic dextrose prolotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hypertonic dextrose prolotherapy
Intervention Description
five intra-articular injection at 2-weeks intervals in weeks 0, 2, 4, 6, 8.
Primary Outcome Measure Information:
Title
Western Ontario McMaster University Osteoarthritis Index
Time Frame
change from baseline at week 10
Secondary Outcome Measure Information:
Title
standing knee X ray posterior-anterior view
Description
the minimum joint space width (mJSW) of the medial and lateral compartment respectively of the tibio-femoral joint
Time Frame
change from baseline at week 10
Title
protein array method for inflammatory factors
Description
Human Angiogenesis Antibody Array
Time Frame
change from baseline at week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Facility Information:
Facility Name
Department of Physical Medicine & Rehabiliation, National Yang-Ming University Hospital
City
Yilan City
ZIP/Postal Code
26042
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not all patients agreed to share primary data to person not related to study
Learn more about this trial
Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array
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