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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05202847
Other study ID # 3-2021-0432
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 7, 2022
Est. completion date December 7, 2022

Study information

Verified date June 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 7, 2022
Est. primary completion date December 7, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pulsed radiofrequency ablation to modifined points group
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.
pulsed radiofrequency ablation to conventional points group
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. during the ablation procedure
Secondary numeric rating score A score of 0 indicates no pain and a score of 10 indicates maximum pain. Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
Secondary 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 Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
Secondary 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. Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
Secondary medication The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations. Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
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