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

NCT02888795 | Completed DMC

• 1 other identifier: RD2016-018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

hypertonic dextrose prolotherapy; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario McMaster University Osteoarthritis Index

  change from baseline at week 10

Secondary Outcomes (2)

• standing knee X ray posterior-anterior view

  change from baseline at week 10

• protein array method for inflammatory factors

  change from baseline at week 10

Study Arms (1)

hypertonic dextrose prolotherapy

EXPERIMENTAL

Drug: hypertonic dextrose prolotherapy

Interventions

hypertonic dextrose prolotherapy DRUG

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

hypertonic dextrose prolotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University Hospital: lead

Study Sites (1)

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

Yilan, 26042, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 5, 2016
• Study Start: February 19, 2016
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)