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

Knee Osteoarthritis Clinical Trial

Official title:

Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05202847
• Other study ID #: 3-2021-0432
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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