Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis

NCT ID: NCT05303766

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-03-31

Brief Summary

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.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Radio-frequency ablation

Intervention Type: DEVICE

Radiofrequency thermocoagulation of the genicular nerves

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.

Group Type: EXPERIMENTAL

Pulsed Radio-frequency

Intervention Type: DEVICE

Intraarticular Pulsed Radiofrequency of the knee

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.

Group Type: EXPERIMENTAL

Intra-articular steroids

Intervention Type: DRUG

Intra-articular steroids for Knee osteoarthritis

Interventions

Radio-frequency ablation

Radiofrequency thermocoagulation of the genicular nerves

Intervention Type: DEVICE

Intra-articular steroids

Intra-articular steroids for Knee osteoarthritis

Intervention Type: DRUG

Pulsed Radio-frequency

Intraarticular Pulsed Radiofrequency of the knee

Intervention Type: DEVICE

Other Intervention Names

Radiofrequency generator; Betafos®; Radiofrequency generator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Mostafa Ali Osman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esraa M Osman, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

Golnar Mohamed Fathy

Role: CONTACT

Golnar_fathy@yahoo.com

01009160566

Ola Mahmoud Wahba

Role: CONTACT

Olawahba69@yahoo.com

01013046017

Other Identifiers

Radiofrequency Ablation KOA

Identifier Type: -

Identifier Source: org_study_id