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Research article
Clinical Efficacy of a Single-dose of Platelet Rich Plasma in the Management of Early Knee Osteoarthritis: A Randomized Controlled Study With Mri Assessment and Evaluation of Optimal Dose
Himanshu Bansal
Anupam Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4224-8632
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Osteoarthritis (OA) causes substantial physical disability that limits a person's ability to indulge in daily activities. Non-steroidal anti-inflammatory drugs provide only minimal symptomatic benefit and are associated with mild to severe side effects, thus limiting its continuous use. This being the case, new alternate healing strategies with minimal adverse effects are being explored scientifically. In our study we have attempted to evaluate the clinical efficacy of a single dose of Platelet Rich Plasma (PRP) in treating osteoarthritis. Our primary objectives are:
i) To optimise the correct dose of PRP preparation to achieve therapeutic relief in knee OA
ii) To identify the therapeutic efficacy of PRP in selected patients suffering from symptomatic primary knee OA through Randomized Clinical Trials and analyse the possible outcome using MRI analysis.
Methods: A randomized, double-blind, 12-month, placebo-controlled study was conducted in 100 outpatients. PRP was prepared from the blood drawn from the subjects and administered intra-articularly guided by ultrasound. The degree of pain was assessed using WOMAC scores, the International Knee Documentation Committee score (IKDC) and six-minute pain free walking distance. The joint space width and articular cartilage thickness was evaluated through x-ray, ultrasonagraphy and MRI.
Result: PRP with absolute count of approximately 100 billion platelets brings out significant therapeutic relief. The WOMAC scores showed reduction from 54.7 at baseline to 28.8 at one month, and 29.9 at 3 months showing efficacy of PRP over placebo. Improvement was evident in one month scores of IKDC tests (Baseline- 53.6; 1 month - 76.9) and VAS (Baseline - 5.8; 1 month - 2.46) followed by slight decline at 3, 6-month and one-year scores. Similarly, the pain-free distance covered during a 6-min walk was significantly improved at one month in both the groups (PRP-146 ft.; placebo-122 ft; p value <0.001). No change is seen on MRI and Joint space width.
Conclusion: 7 times Concentration and absolute count of 100 billion platelets is crucial in a PRP formulation to be therapeutically effective in alleviating symptoms in moderate knee OA. The results indicate prevention of structural modification in the PRP group and better chondroprotective effects compared to placebo group.
Trial Registration: This study has been registered in the US Clinical Trial Registry (U.S. National Library of Medicine) with Trial registration no. 04198467. Date of registration: December 13, 2019. (Retrospectively registered)
URL - https://clinicaltrials.gov/ct2/show/NCT04198467?term=04198467&draw=2&rank=1
Keywords
Osteoarthritis, Platelet-rich plasma, Joint space width, Chondroprotective agents, Nonsteroidal anti-inflammatory drugs
Figure 1
Germain Honvo
commented on 14 June, 2020
Dear Editor, Dear authors, I would like to draw your attention on the fact that the statement "Some studies also showed that CPAs like glucosamine and chondroitin sulphate, when taken alone or in combination, did not effectively reduce the pain caused by OA" (in the introduction) is contrary to the findings of our recent meta-analysis on chondroitin sulfate (reference 6 of the manuscript). Additionally, our meta-analysis did not investigate combination products. Therefore, this statement made by the authors needs to be corrected before the publication of the research reported in this manuscript. Thank you ! Very best regards, Germain Honvo.
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Research article
Clinical Efficacy of a Single-dose of Platelet Rich Plasma in the Management of Early Knee Osteoarthritis: A Randomized Controlled Study With Mri Assessment and Evaluation of Optimal Dose
Himanshu Bansal
Anupam Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4224-8632
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 05 Jun, 2020
Community comments: 1
Metrics
Comments: 1
PDF Downloads: ...
HTML Views: ...
Subject Areas
Plasma and Fluids
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Osteoarthritis (OA) causes substantial physical disability that limits a person's ability to indulge in daily activities. Non-steroidal anti-inflammatory drugs provide only minimal symptomatic benefit and are associated with mild to severe side effects, thus limiting its continuous use. This being the case, new alternate healing strategies with minimal adverse effects are being explored scientifically. In our study we have attempted to evaluate the clinical efficacy of a single dose of Platelet Rich Plasma (PRP) in treating osteoarthritis. Our primary objectives are:
i) To optimise the correct dose of PRP preparation to achieve therapeutic relief in knee OA
ii) To identify the therapeutic efficacy of PRP in selected patients suffering from symptomatic primary knee OA through Randomized Clinical Trials and analyse the possible outcome using MRI analysis.
Methods: A randomized, double-blind, 12-month, placebo-controlled study was conducted in 100 outpatients. PRP was prepared from the blood drawn from the subjects and administered intra-articularly guided by ultrasound. The degree of pain was assessed using WOMAC scores, the International Knee Documentation Committee score (IKDC) and six-minute pain free walking distance. The joint space width and articular cartilage thickness was evaluated through x-ray, ultrasonagraphy and MRI.
Result: PRP with absolute count of approximately 100 billion platelets brings out significant therapeutic relief. The WOMAC scores showed reduction from 54.7 at baseline to 28.8 at one month, and 29.9 at 3 months showing efficacy of PRP over placebo. Improvement was evident in one month scores of IKDC tests (Baseline- 53.6; 1 month - 76.9) and VAS (Baseline - 5.8; 1 month - 2.46) followed by slight decline at 3, 6-month and one-year scores. Similarly, the pain-free distance covered during a 6-min walk was significantly improved at one month in both the groups (PRP-146 ft.; placebo-122 ft; p value <0.001). No change is seen on MRI and Joint space width.
Conclusion: 7 times Concentration and absolute count of 100 billion platelets is crucial in a PRP formulation to be therapeutically effective in alleviating symptoms in moderate knee OA. The results indicate prevention of structural modification in the PRP group and better chondroprotective effects compared to placebo group.
Trial Registration: This study has been registered in the US Clinical Trial Registry (U.S. National Library of Medicine) with Trial registration no. 04198467. Date of registration: December 13, 2019. (Retrospectively registered)
URL - https://clinicaltrials.gov/ct2/show/NCT04198467?term=04198467&draw=2&rank=1
Figure 1
Germain Honvo
commented on 14 June, 2020
Dear Editor, Dear authors, I would like to draw your attention on the fact that the statement "Some studies also showed that CPAs like glucosamine and chondroitin sulphate, when taken alone or in combination, did not effectively reduce the pain caused by OA" (in the introduction) is contrary to the findings of our recent meta-analysis on chondroitin sulfate (reference 6 of the manuscript). Additionally, our meta-analysis did not investigate combination products. Therefore, this statement made by the authors needs to be corrected before the publication of the research reported in this manuscript. Thank you ! Very best regards, Germain Honvo.