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Completed

NCT Number: NCT02888795

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine & Rehabiliation, National Yang-Ming University Hospital

Yilan, 26042, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypertonic dextrose prolotherapy

Drug

five intra-articular injection at 2-weeks intervals in weeks 0, 2, 4, 6, 8.

Primary outcomes

  1. Western Ontario McMaster University Osteoarthritis Index

    Time frame: change from baseline at week 10

Secondary outcomes

  1. standing knee X ray posterior-anterior view

    Time frame: change from baseline at week 10

    the minimum joint space width (mJSW) of the medial and lateral compartment respectively of the tibio-femoral joint

  2. protein array method for inflammatory factors

    Time frame: change from baseline at week 10

    Human Angiogenesis Antibody Array

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University Hospital

Other

Registry information

Official study title

Identification of Early Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by an Inflammation-related Cytokine Array

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2016
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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