Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis

Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency With Steroid Injection in the Pain Management of Knee Osteoarthritis

The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Radio-frequency ablation; Device: Pulsed Radio-frequency; Drug: Intra-articular steroids

Detailed Description

After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Golnar Mohamed Fathy; Phone Number: 01009160566; Email: Golnar_fathy@yahoo.com
• Study Contact Backup: Name: Ola Mahmoud Wahba; Phone Number: 01013046017; Email: Olawahba69@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Inclusion Criteria:

  1. patients diagnosed with KOA based on the American College of Rheumatology criteria
  2. age 18-70 years
  3. grade 2 or 3 KOA based on the Kellgren-Lawrence classification
  4. patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
  5. duration of knee pain ≥ 3 months
  6. numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.

• Exclusion Criteria:

  1. grade 1 or 4 KOA based on the Kellgren-Lawrence classification
  2. severe liver, kidney, cardiovascular, and respiratory disease
  3. abnormal blood coagulation
  4. skin infections in the puncture region
  5. patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
  6. mental disorders or inability to complete the follow-up observational form
  7. patients with bilateral knee pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFT group; The treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds.	Device: Radio-frequency ablation; Radiofrequency thermocoagulation of the genicular nerves; Other Names: Radiofrequency generator
Experimental: IAPRF group; The puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds.	Device: Pulsed Radio-frequency; Intraarticular Pulsed Radiofrequency of the knee; Other Names: Radiofrequency generator
Experimental: IAS group; The puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically.	Drug: Intra-articular steroids; Intra-articular steroids for Knee osteoarthritis; Other Names: Betafos®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS)	Using the numerical rating score , a score from ( 0 to 10 ) for evaluation of pain intensity. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	9 months and after procedure
Oxford Knee Score	Using oxford knee score for follow up of pain of knee osteoarthritis , a score from 0 to 48 . if the score is 0 to 19 this may indicate sever arthritis , and if it's from 40 to 48 it means satisfactory joint function . This scrore is based on a 12-question report about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.	9 months and after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of pain free periods	Duration of pain free periods since the intervention has been done	9 months and after procedure
Site of pain	Patients undergo physical knee examination to determine the site of knee pain at right or left knee , medial or lateral joint line	9 months and after procedure
Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )	Different analgesics used by the patients to alleviate the pain. The patient is asked about how frequent he/she uses an analgesic for pain relief.	9 months and after procedure
Improvement of knee joint function	Using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for evaluation of knee osteoarthritis. t is a self-administered questionnaire consisting of 24 items divided into 3 subscales: 1- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. 2-Stiffness (2 items): after first waking and later in the day. 3- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.	9 months and after procedure

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Esraa M Osman, MBBCH, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

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: Radiofrequency Ablation KOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all collected IPD to be shared
• IPD Sharing Time Frame: Starting in March 2023
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

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