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

Not Applicable

Withdrawn

• Conditions: Knee Osteoarthritis

• Registration Number: NCT05202847
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-12-07
• Primary Completion: 2022-12-07
• Study Completion: 2022-12-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
numeric rating score	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation	A score of 0 indicates no pain and a score of 10 indicates maximum pain.
functional status	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation	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	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation	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	Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation	The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.