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Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulsed radiofrequency ablation to modifined points group
pulsed radiofrequency ablation to conventional points group
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
  2. A score of 6 or higher (out of 10) on the target knee's numerical rating scale
  3. Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment

Exclusion Criteria:

  1. Systemic inflammatory diseases such as rheumatic diseases
  2. uncontrolled diabetes
  3. malignant tumor
  4. If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
  5. Patients with lidocaine and contrast agent allergy
  6. history of nerve block in the target knee within 2 weeks
  7. Body mass index over 40 kg/m2
  8. bleeding disorder
  9. Pregnant/lactating women
  10. Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
  11. Unable to read consent form (e.g. illiterate, foreigner, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    pulsed radiofrequency ablation to modified points group

    pulsed radiofrequency ablation to conventional points group

    Arm Description

    pulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance

    pulsed radiofrequency ablation aimed at conventional target point under C-arm guidance

    Outcomes

    Primary Outcome Measures

    The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
    Whether vascular uptake is confirmed on the x-ray image is a binary response.

    Secondary Outcome Measures

    numeric rating score
    A score of 0 indicates no pain and a score of 10 indicates maximum pain.
    functional status
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints
    quality of life
    Q-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.
    medication
    The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.

    Full Information

    First Posted
    January 10, 2022
    Last Updated
    June 22, 2023
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05202847
    Brief Title
    Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study
    Official Title
    Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    difficulties in recruiting patients with knee osteoarthritis to the pain clinic.
    Study Start Date
    December 7, 2022 (Actual)
    Primary Completion Date
    December 7, 2022 (Actual)
    Study Completion Date
    December 7, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and participants are kept unaware of group assignments.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pulsed radiofrequency ablation to modified points group
    Arm Type
    Experimental
    Arm Description
    pulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance
    Arm Title
    pulsed radiofrequency ablation to conventional points group
    Arm Type
    Active Comparator
    Arm Description
    pulsed radiofrequency ablation aimed at conventional target point under C-arm guidance
    Intervention Type
    Procedure
    Intervention Name(s)
    pulsed radiofrequency ablation to modifined points group
    Intervention Description
    Point 1 place 10mm higher than the boundary between Femur's medial epicondyle and shaft. The 2nd point is targeted 20mm above the patella. Point 3 is targeted 10mm above the femur lateral epicondyle and shaft boundary. At point 4, find the boundary position between the tibia epicondyle and the shaft in the AP view and move it superolateral by 10 mm to target the central part of the medial shaft of the tibia and perform the main touch. Point 5 targets the center of the fibular head.
    Intervention Type
    Procedure
    Intervention Name(s)
    pulsed radiofrequency ablation to conventional points group
    Intervention Description
    Under AP view X-ray fluoroscopy, enter the cannula into the tunnel view until reaching the bone, reaching the border of the shaft and epicondyle, then stop the cannula tip at the anterior 2/3 junction in the lateral view. A total of three target points are the boundary position between the femur medial epicondyle and the shaft, the boundary position between the femur lateral epicondyle and the shaft, and the boundary position between the tibia meidal epiconcyle and the shaft. Subsequent procedure will be proceed same as Arm 1
    Primary Outcome Measure Information:
    Title
    The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
    Description
    Whether vascular uptake is confirmed on the x-ray image is a binary response.
    Time Frame
    during the ablation procedure
    Secondary Outcome Measure Information:
    Title
    numeric rating score
    Description
    A score of 0 indicates no pain and a score of 10 indicates maximum pain.
    Time Frame
    Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
    Title
    functional status
    Description
    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints
    Time Frame
    Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
    Title
    quality of life
    Description
    Q-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.
    Time Frame
    Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
    Title
    medication
    Description
    The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.
    Time Frame
    Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months A score of 6 or higher (out of 10) on the target knee's numerical rating scale Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment Exclusion Criteria: Systemic inflammatory diseases such as rheumatic diseases uncontrolled diabetes malignant tumor If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery) Patients with lidocaine and contrast agent allergy history of nerve block in the target knee within 2 weeks Body mass index over 40 kg/m2 bleeding disorder Pregnant/lactating women Inability to understand informed consent and respond to research questionnaires due to cognitive impairment Unable to read consent form (e.g. illiterate, foreigner, etc.)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study

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