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Monopolar Versus Biopolar Radiofrequency in OA Knee Pain

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monopolar radiofrequency
Bipolar radiofrequency
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  1. Patients with acute knee pain, previous knee surgery, other connective tissue disorders affecting the knee.
  2. serious neurologic or psychiatric disorders, those had previously received radiofrequency ablation therapy for similar symptoms.
  3. 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.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    MBA group monopolar radiofrequency group.

    BFA group bipolar radiofrequency group

    Arm Description

    Inferomedial, superomedial, and superolateral GN branches of the patients were identified with ultrasonography, 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.

    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 90 s in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Time
    Is to compare time taken to complete the procedures

    Full Information

    First Posted
    August 18, 2022
    Last Updated
    October 19, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05591768
    Brief Title
    Monopolar Versus Biopolar Radiofrequency in OA Knee Pain
    Official Title
    The Clinical Efficacy of Monopolar Versus Bipolar Radiofrequency Ablation of the Genicular Nerves in the Treatment of Knee Osteoarthritis Pain.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 14, 2022 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Chronic knee pain due to osteoarthritis (OA) is a debilitating disease. Many therapeutic options have been used to manage this pain . Although there are many pharmacological and surgical treatment options for knee osteoarthritis, these entail a number of concerns. Non-steroidal anti-inflammatory drugs can be used for the initial management of osteoarthritis . Intra-articular corticosteroid injection is another option suggested in the guidelines for the treatment of knee osteoarthritis . Surgical procedures are generally performed in cases unresponsive to the conservative treatment options. Joint replacement is the most commonly performed surgical procedure .Genicular nerve ablation with radiofrequency (RF) has recently become a promising treatment option in the management of osteoarthritis related knee pain. In conventional monopolar radiofrequency ablation (MRFA) technique, the localisation of genicular nerves is done through sensory stimulation at the junction of epicondyle with the shaft of femur bone near periosteum. Added to this, the procedure can be distressing when during localisation of genicular nerves the RF cannula comes in contact with pain-sensitive structures such as the periosteum and ligament insertion sites . Bipolar radiofrequency ablation Two radiofrequency cannula are advanced towards the nerve. The novel idea to use bipolar RFA in this study was to produce a larger lesion, thus may minimize the chance to miss the lesion of genicular nerves. Also Placing two electrodes avoids manipulation required to localise the genicular nerves with inadvertent stimulation of pain-sensitive periosteum . So investigaters need to see experimentally if bipolar radiofrequency ablation (BRFA) near the target nerve area without manipulation for localisation of genicular nerves has the ability to reduce the procedural pain than Monopolar radiofrequency.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MBA group monopolar radiofrequency group.
    Arm Type
    Experimental
    Arm Description
    Inferomedial, superomedial, and superolateral GN branches of the patients were identified with ultrasonography, 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.
    Arm Title
    BFA group bipolar radiofrequency group
    Arm Type
    Experimental
    Arm Description
    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 90 s in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures
    Intervention Type
    Procedure
    Intervention Name(s)
    Monopolar radiofrequency
    Intervention Description
    In monopolar group : . Inferomedial, superomedial, and superolateral GN branches of the patients were identified with ultrasonography, 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Bipolar radiofrequency
    Intervention Description
    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 90 s in both the groups. All procedures were done by one pain physician who had more then 10 years' experience of radiofrequency procedures.
    Primary Outcome Measure Information:
    Title
    Efficacy and procedural pain
    Description
    Is to evaluate the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA) by questionnaire participants
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Time
    Description
    Is to compare time taken to complete the procedures
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (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. Exclusion Criteria: 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. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Mohamed Abo elkasem, Specialist
    Phone
    01023842121
    Email
    me7153991@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hany Ahmed ibrahim, Professor
    Phone
    01005203980
    Email
    elmorabaa@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hany Ahmed ibrahim, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21055873
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24373908
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Monopolar Versus Biopolar Radiofrequency in OA Knee Pain

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