Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04006314
Status:
UNKNOWN
Last Update Posted:
2019-07-05
First Post:
2019-06-26
Brief Title:
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Exploring the Effectiveness of Simultaneous Autologous Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoarthritis OA of the knees is the most common degenerative disorder seen in a rehabilitation outpatient clinic It is characterized by metabolic biochemical and structural changes in the articular cartilage and the surrounding tissues 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 a PRP to treat early stages of knee OA the better the treatment outcome However no consensus has been reached as to whether PRP injection is beneficial for patients with moderate to severe degrees of knee OA Studies have also shown that the application of neural prolotherapy NPT to the genicular nerves may have beneficial effects in treating patients with severe knee OA However patients may start to walk for a longer period of time due to reduced knee pain after NPT If the regenerative effect of PRP is not yet obvious on the knee cartilage this excess walking may result in further destruction of the knee joints No studies have examined the combined treatment effect of a PRP and NPT on patients with moderate to severe degrees of knee OA
NPT is the injection of low percentage dextrose water 5 with the rationale to repair and reduce pain caused by the nerves We would like to bring our PRP study to a higher level by conducting a two-year study to recruit patients with moderate to severe degrees of knee OA PRP will be injected into the knee joint and the pes anserine tendons Simultaneous NPT will also be performed to the genicular nerves The effectiveness will be examined using proteomics isokinetic measurements and functional scale evaluations Synovial fluid SF is in direct contact with the cartilage and synovium protein biomarkers related to the disease pathophysiology of knee OA are contained within the SF and will be used for proteomic analysis Patients will receive monthly injections for a total of 3 months In short if inflammatory proteins in the SF are not reduced after PRP injections this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain more knee joint destruction may result
NPT is the injection of low percentage dextrose water 5 with the rationale to repair and reduce pain caused by the nerves We would like to bring our PRP study to a higher level by conducting a two-year study to recruit patients with moderate to severe degrees of knee OA PRP will be injected into the knee joint and the pes anserine tendons Simultaneous NPT will also be performed to the genicular nerves The effectiveness will be examined using proteomics isokinetic measurements and functional scale evaluations Synovial fluid SF is in direct contact with the cartilage and synovium protein biomarkers related to the disease pathophysiology of knee OA are contained within the SF and will be used for proteomic analysis Patients will receive monthly injections for a total of 3 months In short if inflammatory proteins in the SF are not reduced after PRP injections this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain more knee joint destruction may result
Detailed Description:
Patients will receive monthly injections for a total of 3 months In short if inflammatory proteins in the SF are not reduced after PRP injections this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain more knee joint destruction may result This signifies that NPT has pain reduction effect only and is not a viable treatment option Roentgenograms may not show immediate signs of increased degeneration on the knee joints but SF proteomic findings can provide us with evidences suggesting whether there is ongoing knee joint destruction Upon the completion of this study adequate scientific evidences will be gathered to know whether simultaneous PRP and NPT injections is a feasible option in treating patients with moderate to severe degrees of knee OA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None