Clinical trial NCT06034418: Efficacy of Pulse Radiofrequency Treatment in Patients With Coxarthrosis
Official title: The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coxarthrosis; Primary
Keywords: coxarthrosis
pain
pulse radiofrequency
nerve block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim in this interventional study is to investigate the effectiveness of pulsed radiofrequency (PRF) treatment applied to the articular branches of the femoral and obturator nerves on pain, functional level, functional capacity and quality of life in patients with coxarthrosis. We will compare the effects of PRF treatment added to nerve block compared to nerve block alone.

Detailed description: Hip pain caused by coxarthrosis is common in the general population and is one of the leading causes of disability in the aging population. Conservative treatments may fail due to side effects or ineffectiveness. Surgery is generally recommended for patients who do not respond to conservative treatment. Surgery is not always an appropriate option for elderly patients and patients with multiple comorbidities. For this reason, nerve block may be an appropriate treatment option for patients who do not respond to conservative treatment, who are not suitable for surgery or who do not want surgery. Pulsed radiofrequency (PRF) is a method of temporarily preventing pain transmission through heat increase in the tissue with the help of an electrode placed near the target nerve. Most of the pain sensation in the hip joint is received by the articular branches of the femoral and obturator nerves. The application of PRF to the nerves innervating the hip joint may be an effective method to reduce pain and disability in these patients.

This study was designed as a prospective, randomized, controlled trial. According to the statistical analysis, 28 patients who met the eligibility criteria were planned to be included in the study. The patients will be divided into 2 groups as the block group (n=14) and the PRF group (n=14). In procedures performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. Nerve block and PRF procedures will be performed in sterile conditions according to their protocols. Patients will be evaluated about pain, functional level, functional capacity and quality of life before treatment, at week 2, week 4, and week 12. If complications develop, they will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral and/or bilateral hip pain for more than 6 months who meet the diagnosis of coxarthrosis according to the American College of Rheumatology(ACR) criteria
* Pain intensity greater than 3 according to the visual analog pain scale
* Stage ≥2 hip osteoarthritis according to the Kellgren-Lawrence classification
* Ambulation with or without support
* Having the mental competence to express pain scores
* Signing an informed consent form stating consent to participate in the study

Exclusion Criteria:

* Other non-degenerative causes of hip pain (Avascular necrosis, femoraacetebular impingement syndrome, thoracenteric bursitis)
* Concomitant central nervous system and/or peripheral nervous system disease
* History of lower extremity fracture/surgery in the last 6 months
* Local infection on the hip or presence of systemic infection
* Conditions where fluoroscopy-guided injection is contraindicated like pregnancy, contrast material allergy, local anesthetic allergy, coagulopathy
* Presence of unstable systemic diseases

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, week 2, week 4 and week 12
Secondary outcomes:
measure: Active Range of Motion
timeFrame: baseline, week 2, week 4 and week 12
measure: Passive Range of Motion
timeFrame: baseline, week 2, week 4 and week 12
measure: Harris Hip Score (HHS)
timeFrame: baseline, week 2, week 4 and week 12
measure: Six Minute Walk Test
timeFrame: baseline, week 2, week 4 and week 12
measure: Short From-36 (SF-36)
timeFrame: baseline, week 2, week 4 and week 12
measure: Number of analgesics
timeFrame: baseline, week 2, week 4 and week 12
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References: