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Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis

M

Mansoura University

Status

Unknown

Conditions

Chronic Knee Osteoarthritis

Treatments

Procedure: Platelet rich plasma (PRP)
Procedure: Pulsed radiofrequency (P-RF)

Study type

Interventional

Funder types

Other

Identifiers

NCT03379883
MD/17.01.37

Details and patient eligibility

About

The social impact of degenerative diseases such as articular cartilage pathology and osteoarthritis (OA) is steadily increasing, because of the continued rise in the mean age of the active population. A variety of noninvasive solutions have been proposed for pain treatment, improvement in function and disability, and ultimately, modification of the course of severe cartilage lesions and OA, with variable success rates. Intra articular and genicular nerves radiofrequency (RF) is a minimally invasive technique that usually aims at the neuropathic pain. One important mechanism for the chronic pain mediated by OA is peripheral sensitization, which increases the transmission of pain signals. Through conduction block in pain-transmitting nerve fibers by thermal damage, RF could ease pain without destroying the antennal nerve. The role of growth factors (GFs) in chondral repair is now widely investigated in vitro and in vivo.

Platelet-rich plasma (PRP) is a simple, low cost, and minimally invasive method that allows one to obtain from the blood a natural concentrate of autologous GFs.

Full description

The aim of this study is to compare the efficacy of intra articular Platelet Rich Plasma (PRP) injection versus combined ultrasound guided intra articular and genicular nerve pulsed radiofrequency on chronic knee pain in patients with knee osteoarthritis.

The regeneration capacity of cartilage is limited because of its isolation from systemic regulation and its lack of vessels and nerve supply. Osteoarthritis (OA) has a major impact on functioning and independence and ranks among the top 10 causes of disability worldwide

Enrollment

70 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients experienced unilateral lesion with a history of chronic (≥4 months)
  • Pain or swelling of the knee and imaging findings (radiography or magnetic resonance imaging [MRI]) of degenerative changes of the joint
  • Patients shall to be clinically unresponsive to conservative treatment modalities

Exclusion criteria

  • Diabetes
  • Rheumatic diseases
  • Coagulopathies
  • Severe cardiovascular diseases
  • Infections
  • Immunosuppression
  • Patients receiving anticoagulants
  • Use of non-steroidal anti-inflammatory drugs in the 5 days before blood donation
  • Hemoglobin concentration less than 10 g/dl
  • Platelet count less than 150,000/cubic mm.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups, including a placebo group

Pulsed radiofrequency (P-RF)
Placebo Comparator group
Description:
Patients will receive both intra articular RF and genicular nerve RF ablation
Treatment:
Procedure: Pulsed radiofrequency (P-RF)
Platelet rich plasma (PRP)
Experimental group
Description:
Patients will receive intra-articular platelet rich plasma (PRP)
Treatment:
Procedure: Platelet rich plasma (PRP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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