Clinical trial

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

Name

AnkaraCHBilkent-FTR-FK-01

Description

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.

Trial arms

Trial start

2022-11-25

Estimated PCD

2023-11-25

Trial end

2023-11-25

Status

Completed

Treatment

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℃.

Arms:

Pulse Radiofrequency Group

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.

Arms:

Block Group, Pulse Radiofrequency Group

Size

Primary endpoint

Visual Analogue Scale (VAS)

baseline, week 2, week 4 and week 12

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2024-02-08

1 organization

1 product

1 indication

Organization

Ankara City Hospital Bilkent

Product

Nerve block

Indication

Coxarthrosis