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Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis

NCT04006314 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Autologous platelet rich plasma and dextrose solution.

Autologous platelet rich plasma are injected into the knee joint and pes anserinus complex. Dextrose solutions are injected to the genicular nerves.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Carl P.C. Chen, MD, PhD · Chang Gung Memorial Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04006314 on ClinicalTrials.gov