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Clinical Trial Summary

Introduction : Prolotherapy is regenerative tissue therapy which is considered to be efficacious in reducing symptoms and morbidity of Knee Osteoarthritis (KOA), but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Cartilage Oligomeric Matrix Protein (COMP), and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) as the biomarkers of cartilage repair. Objective: To determine the effect of prolotherapy on COMP and uCTX-II levels, and functional outcomes in KOA patients. Method: a double-blind randomized controlled trial study involving 36 participants who had been diagnosed with KOA. History taking, functional outcome assessment, COMP, and uCTX-II were measured. The prolotherapy via intraarticular and extraarticular was performed at Day-1, Day-29, and Day-57 followed by the evaluation of functional outcome, COMP, and uCTX-II at day 78 Alternative Hypothesis : Prolotherapy provides improvement of cartilage based on COMP and UCTX-II levels and functional outcome among KOA patients

Clinical Trial Description

Design : Double-blind randomized trial Randomization : Simple Randomization generated by an online randomizer Sample Size : Difference between two means of primary outcome where 1. mean difference (μ 1 - μ 2 ) = 0.05 2. pool variance = 0.09 3. Z 1-α/2 = 1.95 with type 1 error 5% 4. 1-β = 1.282 with power 90%. Yielding 16 patients for each arm Time Period of Recruitment September 2019- August 2020 Detailed Intervention 1. Intervention group : Prolotherapy given three times (Day-1, Day-29, and Day-57 ) 2. Comparison group : Hyaluronate given five times (Day-1, Day-8, Day-15, Day-22, and Day-29.) Outcome Measurement : 1. Cartilage Oligomeric Matrix Protein (COMP) Source of Sample : Median Cubital Vein Whole Blood Measurement : Enzyme-linked Immunoassay 2. Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) Source of Sample : 50 cc of random urine sample Measurement : Enzyme-linked Immunoassay 3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for functional Outcome (self-reported assessment) Domains : 1. five elements of pain (score range 0-20), 2. two for stiffness (score range 0-8), 3. 17 for functional limitation (score range 0-68) Classification : 0 - 24 : Mild 25 - 48 : Moderate 49 - 72 : Severe 73 - 96 : Extremely Severe Statistical analysis : 1. Descriptive statistic to elaborate baseline characteristic 2. Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for non parametric data 3. Difference within group (baseline and last day) will be measured by paired-t test or wilcoxon for non parametric scenario ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04557943
Study type Interventional
Source Hasanuddin University
Status Completed
Phase Phase 4
Start date September 1, 2019
Completion date August 1, 2020

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