NCT06034418

Efficacy of Pulse Radiofrequency Treatment in Patients With Coxarthrosis

The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coxarthrosis; Primary

Interventions

Type	Name	Description
DEVICE	Pulse radiofrequency treatment	In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, pulse radiofrequency will be applied to each nerve in 2 cycles of 120 seconds for the patients in this group. The pulse radiofrequency current will be 20 milliseconds wide and 45 volts in size. The tip temperature shall not be more than 42℃.
DRUG	Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine	In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.

Timeline

• Start date: 2022-11-25
• Primary completion: 2023-11-25
• Completion: 2023-11-25
• First posted: 2023-09-13
• Last updated: 2024-02-08

Locations

1 site across 1 country: Turkey (Türkiye)