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

Chronic Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03379883
• Other study ID #: MD/17.01.37
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 15, 2017
• Start date: September 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: December 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: February 1, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University, Emergency Hospital, Intensive Care Unit	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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