Clinical trial NCT03379883: Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis
Official title: Combined Ultrasound Guided Genicular Nerve and Intra-articular Pulsed Radiofrequency Versus Intra-articular Platelet Rich Plasma Injection for Chronic Knee Osteoarthritis; A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Knee Osteoarthritis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Pain score
timeFrame: For 6 months after intervention
Secondary outcomes:
measure: Knee function
timeFrame: For 6 months after intervention
measure: Patient satisfaction
timeFrame: For 6 months after intervention
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Emergency Hospital, Intensive Care Unit
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohammed A Sultan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Doaa G Diab, MD
role: STUDY_CHAIR
References: