The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pulse Radiofrequency Group
Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.
干预措施: Pulse radiofrequency treatment (Device)
Pulse Radiofrequency Group
Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.
干预措施: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine (Drug)
Block Group
For the patients in the block group, nerve block will be performed by applying 1 cc betamethasone and 1 cc 1% lidocaine for each nerve.
干预措施: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: baseline, week 2, week 4 and week 12
Visual Analogue Scale (VAS) is one of the pain rating scales. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (extreme pain). At rest, with movement, nighttime VAS scores and averages of them will be recorded.
次要结局
- Active Range of Motion(baseline, week 2, week 4 and week 12)
- Passive Range of Motion(baseline, week 2, week 4 and week 12)
- Harris Hip Score (HHS)(baseline, week 2, week 4 and week 12)
- Six Minute Walk Test(baseline, week 2, week 4 and week 12)
- Number of analgesics(baseline, week 2, week 4 and week 12)
- Short From-36 (SF-36)(baseline, week 2, week 4 and week 12)
研究者
Fatıma Korkmaz
MD
Ankara City Hospital Bilkent