High Frequency Intensive Autologous PRP Injection and Genicular Nerve Blocks in Treating Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04088045|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 8, 2019
Osteoarthritis (OA) of the knees is the most common degenerative disorder seen in a rehabilitation outpatient clinic. It is characterized by structural changes in the articular cartilage and the surrounding tissues. The understanding of its pathophysiology is still unclear. Knee OA patients are often troubled with knee pain and functional disturbance. Several studies have shown that the earlier the injection of autologous platelet rich plasma (PRP) to treat early stages of knee OA, the better the treatment outcome. However, there are controversies as to whether PRP injections can also be effective in treating patients with moderate to severe degrees of knee OA. Synovial fluid (SF) is in contact with the primary tissues affected by OA (cartilage and synovium). Identifying the SF biomarkers can provide us with crucial information in monitoring the PRP treatment response.
PRP is blood plasma that is rich in autologous platelets. Platelet releases growth factors and cytokines that can stimulate the healing of soft tissue structures. However, the amount of platelets in human blood is not concentrated. Purification and centrifugation procedures are needed to concentrate these platelets. The human knee cartilage is contained inside the knee joint and has scarce blood supply. When the cartilage is injured, growth factors can hardly reach this area to repair the cartilage. Therefore, many studies have suggested early usage of PRP in treating knee OA. Some studies have stated that the effect of PRP in treating knee OA is superior to that of hyaluronic acid (HA). Recent studies have recommended the application of high frequency PRP injections (ex/ intra-articular (IA) PRP injections on a weekly basis) in treating patients with more severe degrees of knee OA. Prolotherapy using hyperosmolar dextrose solution has been shown to have some positive effectiveness in treating patients with knee OA. Higher percentage, such as > 12.5% of dextrose water, may stimulate cartilage repair. Lower percentage, such as 5% dextrose water, has been documented to play an essential role in anti-inflammation, and pain reduction.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Autologous platelet rich plasma and 5% dextrose solution injections.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Patients are divided into three groups. Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution.|
|Masking:||None (Open Label)|
|Official Title:||Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Receiving PRP injections or PRP plus neural prolotherapy
This experiment compares the effect of injecting PRP alone into the knee joint and pes anserinus complex with when dextrose solution is also injected to the genicular nerves.
The injection of dextrose solution is to decrease the inflammation of the genicular nerves, hoping to further effectively alleviate the knee pain condition. Therefore, upon the conclusion of this study, we can see whether the inclusion of dextrose injection in addition to PRP treatment can really be effective in treating patients with more severe degrees of knee OA.
Device: Autologous platelet rich plasma and 5% dextrose solution injections.
One group of patients will receive autologous platelet rich plasma injection into the knee joint and pes anserinus complex. The other group will receive both PRP injections into the knee joint and pes anserinus complex, and prolotherapy of 5% dextrose solution to the genicular nerves.
Dextrose solutions are injected to the genicular nerves.
- Lequesne knee osteoarthritis questionnaire [ Time Frame: About 10 minutes are required to evaluate the score of LeQuesne index. ]Lequesne knee osteoarthritis functional index includes distance, pain, and function. When added, an index score of > 7 indicates the possibility of knee osteoarthritis. The higher the score, the more severeness of knee osteoarthritis. When the index score is less than 7, the possibility of knee osteoarthritis is not high.
- Two-dimensional electrophoresis (proteomics) [ Time Frame: Two days are required to measure the protein band intensities on the gels. ]Hundreds of protein spots can be viewed on 2-dimensional electrophoresis gels. The intensity of each spot represents protein concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088045
|Contact: Shu-Yi Tseng||03-3196200 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 33343|
|Contact: Shu-Yi Tseng 03-3196200 ext 3706 firstname.lastname@example.org|
|Principal Investigator:||Carl P.C. Chen||Chang Gung Memorial Hospital|