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

NCT03379883 | Unknown DMC

• 1 other identifier: MD/17.01.37
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knee function

  For 6 months after intervention

• Patient satisfaction

  For 6 months after intervention

Study Arms (2)

Pulsed radiofrequency (P-RF)

PLACEBO COMPARATOR

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

Procedure: Pulsed radiofrequency (P-RF)

Platelet rich plasma (PRP)

EXPERIMENTAL

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

Procedure: Platelet rich plasma (PRP)

Interventions

Pulsed radiofrequency (P-RF) 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

Pulsed radiofrequency (P-RF)

Platelet rich plasma (PRP) 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

Platelet rich plasma (PRP)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Emergency Hospital, Intensive Care Unit

Al Mansurah, DK, 050, Egypt

Location

Study Officials

• Mohammed A Sultan, MD

  Professor of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

• Doaa G Diab, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind (investigator) study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: September 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: February 1, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

EG (1)