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

NCT ID: NCT03379883

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-02-01

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

Conditions

Chronic Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Pulsed radiofrequency (P-RF)

Patients will receive both intra articular RF and genicular nerve RF ablation

Group Type: PLACEBO_COMPARATOR

Pulsed radiofrequency (P-RF)

Intervention Type: PROCEDURE

Intra articular RF

Insertion of the RF cannula within the joint. The recommended parameters are a pulse width of 20 msec and a rate of 2 Hz at 42°C for 10min.

Genicular nerve RF ablation.

The RF probe will be placed. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.6 V

Platelet rich plasma (PRP)

Patients will receive intra-articular platelet rich plasma (PRP)

Group Type: EXPERIMENTAL

Platelet rich plasma (PRP)

Intervention Type: PROCEDURE

Under ultrasound guidance while the patients in a sitting position. In total, 3 to 8 mL of PRP will be injected via the inta-articular route

Interventions

Pulsed radiofrequency (P-RF)

Intra articular RF

Insertion of the RF cannula within the joint. The recommended parameters are a pulse width of 20 msec and a rate of 2 Hz at 42°C for 10min.

Genicular nerve RF ablation.

The RF probe will be placed. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.6 V

Intervention Type: PROCEDURE

Platelet rich plasma (PRP)

Under ultrasound guidance while the patients in a sitting position. In total, 3 to 8 mL of PRP will be injected via the inta-articular route

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed A Sultan, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Anesthesia and Surgical Intensive Care

Doaa G Diab, MD

Role: STUDY_CHAIR

Assistant Professor of Anesthesia and Surgical Intensive Care

Locations

Mansoura University, Emergency Hospital, Intensive Care Unit

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MD/17.01.37

Identifier Type: -

Identifier Source: org_study_id