search
Back to results

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
National Yang Ming Chiao Tung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring hypertonic dextrose prolotherapy, osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 24, 2016
Last Updated
December 28, 2018
Sponsor
National Yang Ming Chiao Tung University Hospital
search

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

We'll reach out to this number within 24 hrs