Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis

NCT05303766 | Unknown DMC

• 1 other identifier: Radiofrequency Ablation KOA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Duration of pain free periods

  9 months and after procedure

• Site of pain

  9 months and after procedure

• Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )

  9 months and after procedure

• Improvement of knee joint function

  9 months and after procedure

Study Arms (3)

RFT group

EXPERIMENTAL

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

IAPRF group

EXPERIMENTAL

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

IAS group

EXPERIMENTAL

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

Interventions

Radio-frequency ablation DEVICE

Radiofrequency thermocoagulation of the genicular nerves

Also known as: Radiofrequency generator

RFT group

Intra-articular steroids DRUG

Intra-articular steroids for Knee osteoarthritis

Also known as: Betafos®

IAS group

Pulsed Radio-frequency DEVICE

Intraarticular Pulsed Radiofrequency of the knee

Also known as: Radiofrequency generator

IAPRF group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with KOA based on the American College of Rheumatology criteria
• age 18-70 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
• patients with bilateral knee pain.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Radiofrequency Ablation; Steroids; Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Fused-Ring Compounds; Polycyclic Compounds; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Esraa M Osman, MBBCH

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Golnar Mohamed Fathy

CONTACT

01009160566; Golnar_fathy@yahoo.com

Ola Mahmoud Wahba

CONTACT

01013046017; Olawahba69@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting in March 2023
• Access Criteria: Open access

Locations

EG (1)