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

Not Applicable

• Conditions: Chronic Knee Osteoarthritis
• Interventions: Procedure: Pulsed radiofrequency (P-RF); Procedure: Platelet rich plasma (PRP)

• Registration Number: NCT03379883
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-15
• Last Update Submitted: 2017-12-15
• Study First Posted: 2017-12-20
• Last Update Posted: 2017-12-20
• Primary Completion: 2018-08-31
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed radiofrequency (P-RF)	Pulsed radiofrequency (P-RF)	Patients will receive both intra articular RF and genicular nerve RF ablation
Platelet rich plasma (PRP)	Platelet rich plasma (PRP)	Patients will receive intra-articular platelet rich plasma (PRP)

Primary Outcome Measures

Name	Time	Method
Pain score	For 6 months after intervention	The intensity of pain at rest will be measured with a 10-cm visual analogue scale (VAS-pain). (VAS) identifying 0 as no pain and 10 as worst imaginable pain.

Secondary Outcome Measures

Name	Time	Method
Knee function	For 6 months after intervention	Subjective knee functionality will be evaluated using the Western Ontario and McMaster's Universities Osteoarthritis (WOMAC) Index.WOMAC Index assesses disability in three subscales, including pain, severity of physical function and joint stiffness. This scale consists of 24 items: five items for pain assessment, two items for assessment of the severity of joint stiffness and 17 items for assessment of physical function. The patient answers the questions and then receives a cumulative score in each of the 3 areas (pain, 0-20; stiffness, 0-8; physical function, 0-68). Higher scores are representative of greater pain and stiffness as well as worsened physical capability.
Patient satisfaction	For 6 months after intervention	Patient satisfaction when it comes to perceived improvement in symptoms after the treatment will evaluated using the Patient Global Impression Scale of Improvement (PGI-I) where; Very much better = 1, Much better = 2, A little better= 3, No change =4, A little worse=5, Much worse=6, Very much worse =7,

Trial Locations

Locations (1)

Mansoura University, Emergency Hospital, Intensive Care Unit; 🇪🇬 Mansourah, DK, Egypt