Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis

NCT04006314 | Unknown

• 1 other identifier: 201701924A3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

platelet rich plasma; neural prolotherapy

Outcome Measures

Primary Outcomes (2)

• Lequesne knee osteoarthritis questionnaire

  Lequesne knee osteoarthritis functional index which includes distance, pain, and function.

  About 10 minutes are required to evaluate the score of LeQuesne index.

• Two-dimensional electrophoresis (proteomics)

  Hundreds of protein spots can be viewed on 2-dimensional electrophoresis gels. The intensity of each spot represents protein concentration.

  Two days are required to measure the protein band intensities on the gels.

Study Arms (1)

Receiving PRP injections or PRP plus neural prolotherapy

OTHER

PRP injection into the knee joint and pes anserinus complex. Dextrose solution to the genicular nerves.

Other: Autologous platelet rich plasma and dextrose solution.

Interventions

Autologous platelet rich plasma and dextrose solution. OTHER

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

Receiving PRP injections or PRP plus neural prolotherapy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited.
• The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance.
• Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study.
• Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function.
• The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region.

You may not qualify if:

• Total obliteration of knee joint as shown on the roentgenogram images.
• Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus \>5°, valgus \>5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression.
• Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest.
• Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33343, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Carl P.C. Chen, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Yi Tseng

CONTACT

03-3196200; tsengshui@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Physical Medicine & Rehabilitation

Model Details: Patients are divided into two groups. One group receiving PRP injections only. One group receiving PRP plus neural prolotherapy injections.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: September 4, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)