Radiofrequency Ablation on Pain Relief of Knee Osteoarthritis

NCT05050396 | Unknown

• 1 other identifier: Pain relief of osteoarthritis
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction Osteoarthritis (OA) is a chronic, progressive disease with high disability and teratogenicity in the joints. Deterioration of the articular cartilage is the main problem associated with osteoarthritis, which decreases joint space between the two bones\[1\]. Clinically, patients with knee OA typically present with a chief complaint of pain, often associated with limited range of motion, stiffness, osteophytes, crepitus, and effusions. Due to the progressive degenerative nature of OA and the associated pain, patients become more physically impaired through the course of the disease \[6\]. One of the main tissues affected by this disease is the articular cartilage, which is a thin tissue covering the bony end in the joint that mainly provides mechanical support and lubrication during joint movement \[7\]. Age, previous knee injuries, but also obesity(increased body mass index(BMI)) ,joint malalignment and instability that result in increased mechanical stress are all strong risk factors for the development of knee OA \[8-10\]. Magnetic resonance imaging (MRI), arthroscopy examination, high-frequency color ultrasound and thermal texture maps are the four most acceptable types of imaging examinations. These examinations cannot only help diagnose KOA, but they can also assess the severity of joint damage and evaluate disease progression and treatment \[11,12\]. Treatment options for patients with OA include: conservative approaches, such as weight loss, physical therapy, and pharmacological interventions, while the more invasive approaches include intraarticular injections, joint preserving surgical treatment, and total knee arthroplasty (TKA). \[13, 14\] Radiofrequency ablation (RFA) is a novel technique that also recently gained popularity in alleviating chronic pain in patients with musculoskeletal disorders such as OA \[15\] Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). \[16, 17\]

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.

  The primary outcome will be the ability to compare between cooled versus Thermocoagulant RF in the change from the baseline of the VAS for pain at the completion of treatment at 24 weeks.

  24weeks

Study Arms (2)

Cooled radio frequency

EXPERIMENTAL

In CRF, water circulates inside the probe to remove heat, modulating the thermal heat in the tissue to around 60°C, and alters the overall size, shape, and projections of lesions compared to conventional RFA. It is postulated that the greater sized CRF lesions may reduce the number of technical failures in the setting of a complex and variable neuronal innervation to the knee. The ability to target a greater amount of neuronal tissue is believed to produce long-term pain relief at least to the duration of relief produced by conventional RFA \[27\]

Procedure: Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis

Thermocoagulant radio frequency

EXPERIMENTAL

Conventional radiofrequency Ablation RFA of the knee can be performed under fluoroscopic, or other imaging, guidance, with a cannula advanced into the joint towards the area connecting the shaft to the epicondyle. The area is stimulated to identify the nerve position and to ensure that no motor nerves are activated, as evidenced by absence of fasciculations. The RF electrode is then advanced through the cannula to the target area \[18\] The electrode tip heats up targeted local tissue within a few millimeters to a temperature typically greater than 47°C (ranging from 70°C to 90°C) for 120 130 seconds, generated through an electromagnetic field with a frequency of 250 kHz . \[15,18\] The ablative heat is provided via flow of electrical current, generating a well-delineated lesion \[24\]

Procedure: Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis

Interventions

Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis PROCEDURE

Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). \[16, 17\] Similar to conventional RFA, water-cooled radiofrequency (CRF) ablation is a novel technology that utilizes thermal ablative mechanisms; however, CRF gives the ability to create a greater local neuronal lesion to increase the changes of effective denervation \[20\]

Cooled radio frequency; Thermocoagulant radio frequency

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intractable knee pain intensity \>5 on an 11-point visual analog scale (VAS) (where 0=no pain and 10=worst pain imaginable) for longer than three months and unable to do knee replacement surgery.
• Age \> 50 years.
• Grade 2 or 3 KOA based on the Kellgren-Lawrence classification.
• Patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months.
• Duration of knee pain ≥ 3 months.
• Numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.

You may not qualify if:

• Grade 1 or 4 KOA based on the Kellgren-Lawrence classification.
• Severe liver, kidney, cardiovascular, and respiratory disease.
• Abnormal blood coagulation.
• Skin infections in the puncture region.
• Patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF.
• Mental disorders or inability to complete the follow-up observational form.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mohamed MM Mostafa, A, professor

  Assiut University

  STUDY DIRECTOR

• Ahmed AA Abd elrahman, Doctor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Saif eldeen SE Gamal, Master

CONTACT

+20 103 389 3202; saifeldeen616@gmail.com

Mohamed Mb Hassan Bakri, Professor

CONTACT

+20 106 635 6375; mhbakri@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-06