Monopolar Versus Biopolar Radiofrequency in OA Knee Pain

NCT05591768 | Completed DMC

• 1 other identifier: Radiofrequency in OA knee pain
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Efficacy and procedural pain

  Is to evaluate the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA) by questionnaire participants

  Baseline

Secondary Outcomes (1)

• Knee pain and function

  2 years

Study Arms (2)

MBA group monopolar radiofrequency group.

EXPERIMENTAL

Inferomedial, superomedial, superolateral GN branches and nerve to vastus intermediate of the patients were identified with fluoroscopy, and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be \< 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz.

Procedure: Monopolar radiofrequency

BFA group bipolar radiofrequency group

EXPERIMENTAL

similar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures

Procedure: Bipolar radiofrequency

Interventions

Monopolar radiofrequency PROCEDURE

In monopolar group : . Inferomedial, superomedial, superolateral GN branches and nerve to vastus intermedius of the patients were identified with fluoroscopy and a 22 Gauge, 10 cm radiofrequency (RF) cannula with a 10 mm active tip was advanced to the targeted nerves under fluoroscopy guidance. The location of the RF cannula was visualized by anteriorposterior and lateral images. Sensory stimulation was applied at 50 Hz to determine the nerve position. Since the sensory stimulation threshold must be \< 0.6 V, nerve position was tested with the absence of fasciculation in the relevant area of the lower extremity upon 2.0 V stimulation at 2 Hz.

MBA group monopolar radiofrequency group.

Bipolar radiofrequency PROCEDURE

a similar technique will be used to insert the canula, except that, instead of one cannula two cannulae (approximately 10 mm apart) apart) will be inserted and no manipulation of cannulae was done to stimulate the target nerve as done in MRFA Target areas were similar to monopolar technique Each nerve will be ablated for 2 minutes in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures.

BFA group bipolar radiofrequency group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) outpatient clinic with osteoarthritis-character chronic knee pain, OA grades II-IV (Kellgren and Lawrence scale).
• (2) Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
• (3) Patients refused surgery. (4) Patients after failed conservative treatment for 3 months and reported more than 50% pain relief after diagnostic genicular nerve block with 2% of 2 mL lidocaine on superior lateral, superior medial and inferior medial genicular nerves.

You may not qualify if:

• Patients with acute knee pain, previous knee surgery, other connective tissue disorders affecting the knee.
• serious neurologic or psychiatric disorders, those had previously received radiofrequency ablation therapy for similar symptoms.
• contraindications for genicular nerve block or genicular nerve RF (active infection, bleeding disorders, current use of anticoagulants or antiplatelets, allergy against the drugs used during the protocol, pregnancy, cardiac pacemaker.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University hospitals

Asyut, Egypt

Location

Related Publications (2)

• Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

  PMID: 21055873 RESULT

• Protzman NM, Gyi J, Malhotra AD, Kooch JE. Examining the feasibility of radiofrequency treatment for chronic knee pain after total knee arthroplasty. PM R. 2014 Apr;6(4):373-6. doi: 10.1016/j.pmrj.2013.10.003. Epub 2013 Dec 27.

  PMID: 24373908 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Hany Ahmed ibrahim, Professor

  Assiut University

  STUDY CHAIR

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 investigatr

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: October 24, 2022
• Study Start: November 14, 2022
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 6, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)