Identification of Response to Hypertonic Dextrose Prolotherapy Markers in

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02888795
Study type	Interventional
Source	National Yang-Ming University Hospital
Contact
Status	Completed
Phase	N/A
Start date	February 19, 2016
Completion date	May 26, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Identification of Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by Cytokine Array

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms