Clinical trial NCT05447624: The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis
Official title: The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Radiofrequency Ablation
Genicular Nerve
Keywords: Osteoarthritis Knee
Genicular Nerve
Radiofrequency Ablation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. In imaging techniques applied with weight-bearing, varying degrees of joint narrowing are observed, although it is more common in the medial. Treatment options include conservative approaches such as weight loss, physical therapy, analgesics, or invasive approaches such as intra-articular injections, peripheral nerve blocks, joint-sparing surgery or total knee replacement. Surgical operation should be considered in the treatment when conservative treatments are insufficient. However, the advanced age of this patient group and the large number of comorbidities reduce the possibility of surgical operation. Although treatment cannot be cured in knee osteoarthritis, the aim of the treatment is to decrease the pain, increase the patient's quality of life and physical capacity, and slow down the progression of the disease.

Although the radiofrequency ablation (RFA) technique has been used since the 1970s, the first application area was trigeminal neuralgia. Later, its use in neck and back pain became widespread, but the first randomized controlled study on its use in knee osteoarthritis was Choi et al. Made by in 2011. The purpose of radiofrequency ablation applied to the genicular nerves that receive the sensation of the knee joint capsule is to prevent sensory transmission and reduce the sensation of pain by creating axonal damage to these nerves. Since the use of RFA in knee osteoarthritis is relatively new, studies on the development of the technique continue. Fluoroscopy device or ultrasonography can be used as imaging method to show target nerves or to place the RFA electrode in the correct localization.

The investigators hypothesis; based on the more prominent medial involvement in knee osteoarthritis, the conventional RFA procedure applied to the 3 genicular nerves (SMGN, IMGN, SLGN) is not superior to the RFA procedure applied to the medial SMGN and IMGN branches.


Eligibility criteria: Inclusion Criteria:

* Be over 50 years old and under 80 years old
* Symptom duration is at least 3 months
* Pre-procedure NRS score of more than 6
* Kellgren-Lawrence stage 3-4
* Failure to respond to conservative treatments
* Having given consent to participate in the study
* The patient's ability to speak and read and write Turkish

Exclusion Criteria:

* Body mass index of 41 kg/m2 or more
* Acute knee injury
* Chronic pain syndrome (fibromyalgia syndrome, chronic fatigue syndrome, etc.)
* Lumbar radicular pain
* Uncontrolled diabetes mellitus
* Presence of bleeding diathesis
* Hemodynamic instability
* Pacemaker presence
* History of septic arthritis or active local or systemic infection
* Having a history of surgery on the knee to be treated
* Intra-articular injection of the knee within 3 months
* Cognitive impairment
* Presence of genu valgus deformity
* Presence of secondary knee osteoarthritis (due to trauma, rheumatoid arthritis, systemic inflammatory diseases such as gout, kinetic chain disorder due to congenital hip dislocation)

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: 3 months
measure: SF-36 (Short Form-36)
timeFrame: 3 months
measure: TUG (Timed Up and Go Test)
timeFrame: 3 months
measure: use of analgesic drugs
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: