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

Combined Ultrasound Guided Genicular Nerve and Intra-articular Pulsed Radiofrequency Versus Intra-articular Platelet Rich Plasma Injection for Chronic Knee Osteoarthritis; A Comparative Study

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Knee Osteoarthritis
• Intervention / Treatment: Procedure: Pulsed radiofrequency (P-RF); Procedure: Platelet rich plasma (PRP)

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University, Emergency Hospital, Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Pulsed radiofrequency (P-RF); Patients will receive both intra articular RF and genicular nerve RF ablation	Procedure: 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
EXPERIMENTAL: Platelet rich plasma (PRP); Patients will receive intra-articular platelet rich plasma (PRP)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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.	For 6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee function	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.	For 6 months after intervention
Patient satisfaction	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,	For 6 months after intervention

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohammed A Sultan, MD, Professor of Anesthesia and Surgical Intensive Care; Study Chair: Doaa G Diab, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MD/17.01.37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No