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Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis

NCT ID: NCT06173830

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-04-15

Brief Summary

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The aim of this study is to compare the effects of conventional physiotherapy methods with ultrasound-guided radiofrequency ablation of the genicular nerve on pain and functional status in patients with stage 2-3 chronic knee osteoarthritis.

Detailed Description

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Patients diagnosed with Chronic Knee Osteoarthritis according to the American College of Rheumatology criteria, and with radiological osteoarthritis at Kellgren-Lawrence grades 2 and 3, within the age range of 45-70, and meeting the study criteria will be included in the study. After providing information about the procedures to be performed and potential risks to the patients, if they give their written informed consent, treatment methods will be applied to the patients. Eligible patients will be divided into two groups. In one group, Radiofrequency Ablation of the Genicular Nerve under Ultrasound Guidance will be performed, while the other group will receive physical therapy.

Conditions

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Chronic Knee Osteoarthritis

Keywords

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knee osteoarthritis genicular nerve block Ultrasound radiofrequency Chronic pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound-guided radiofrequency ablation of the genicular nerve in chronic knee osteoarthritis

A total of 34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type OTHER

34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.

physical therapy for chronic knee osteoarthritis

Thirty-four patients with chronic knee osteoarthritis meeting the criteria will receive 10 sessions of physical therapy.

Group Type ACTIVE_COMPARATOR

physical therapy

Intervention Type OTHER

34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.

Interventions

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radiofrequency ablation

34 patients with chronic knee osteoarthritis meeting the criteria will undergo ultrasound-guided radiofrequency ablation of the genicular nerve.

Intervention Type OTHER

physical therapy

34 patients with chronic knee osteoarthritis meeting the criteria will undergo 10 sessions of physical therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* VAS ≥ 5
* To be aged between 45 and 70 years old
* Patients diagnosed with chronic knee osteoarthritis using the American College of Rheumatology criteria and having radiological osteoarthritis of Kellgren-Lawrence grade 2 and 3
* Cognitive functions being intact
* Being willing to participate in the study and signing the consent forms

Exclusion Criteria

* Having received physical therapy for chronic knee osteoarthritis in the last 6 months
* Having received glucocorticoid or hyaluronic acid injections in the last 6 months
* Having taken oral glucosamine
* Undergoing knee surgery
* Having current neurological or mental disorders
* History of pacemaker usage
* Presence of local infections or sepsis
* Progressive neurological deficit
* Presence of oncological diseases
* Hemorrhagic diathesis or anticoagulation
* Uncontrolled diabetes or other serious internal comorbidities
* Allergy to medications or materials used
* Pregnancy
* Lack of cooperation
* Not willing to participate in the study.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Merve Çakır

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent - Çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatma Gül Yurdakul, Associate Professor (medical)

Role: CONTACT

Phone: +905059254214

Email: [email protected]

Facility Contacts

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Merve Çakır, Medical Doctor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21055873 (View on PubMed)

McCormick ZL, Korn M, Reddy R, Marcolina A, Dayanim D, Mattie R, Cushman D, Bhave M, McCarthy RJ, Khan D, Nagpal G, Walega DR. Cooled Radiofrequency Ablation of the Genicular Nerves for Chronic Pain due to Knee Osteoarthritis: Six-Month Outcomes. Pain Med. 2017 Sep 1;18(9):1631-1641. doi: 10.1093/pm/pnx069.

Reference Type BACKGROUND
PMID: 28431129 (View on PubMed)

Kesikburun S, Yasar E, Uran A, Adiguzel E, Yilmaz B. Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Pain Physician. 2016 Jul;19(5):E751-9.

Reference Type RESULT
PMID: 27389118 (View on PubMed)

Other Identifiers

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10026603

Identifier Type: -

Identifier Source: org_study_id