Clinical trial NCT06173830: Ultrasound-guided Radiofrequency Ablation of the Genicular Nerve Versus Physical Therapy for Chronic Knee Osteoarthritis
Official title: Comparison of the Effectiveness of Physical Therapy With Ultrasound-Guided Radiofrequency Ablation of the Genicular Nerve in Patients With Chronic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Knee Osteoarthritis
Keywords: knee osteoarthritis
genicular nerve block
Ultrasound
radiofrequency
Chronic pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Before treatment (initial), after 2 weeks and 12 weeks changes
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Before treatment (initial), after 2 weeks and 12 weeks changes
measure: The 6-minute walk test (6MWT)
timeFrame: Before treatment (initial), after 2 weeks and 12 weeks changes
measure: EuroQol scale (EQ-5D-3L)
timeFrame: Before treatment (initial), after 2 weeks and 12 weeks changes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Bilkent - Çankaya
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.