Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
概览
简要总结
Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. In addition to diagnostic and treatment costs, it can lead to serious physical disability, resulting in loss of workforce and placing a substantial economic burden on countries. Many different factors play a role in the etiology of low back pain. According to etiology, it can be classified as idiopathic, mechanical, rheumatologic, metabolic, endocrine, infectious, neoplastic, neurologic/psychiatric disorders, and pain of visceral origin. The treatment of low back pain can be classified into medical treatment, physical therapy, percutaneous invasive interventions, and surgical intervention. TECAR therapy is also one of the treatment modalities routinely used in clinical practice. Our aim is to develop more effective physical therapy programs.
详细描述
The study is planned as a prospective, randomized, double-blind trial. According to power analysis, 54 patients will be included to achieve 95% power. Eligible participants will be women or men aged 20-60 years who are diagnosed with lumbar disc herniation, have low back pain lasting longer than 12 weeks, present to the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, and consent to participate in the study.
According to the study criteria, initial evaluations will be performed by a single Physical Medicine and Rehabilitation physician. Demographic data of eligible patients, including age, sex, height, weight, occupation, and systemic diseases, will be recorded.
Patients will be evaluated before treatment, immediately after treatment, and one month after the end of treatment using the following scales: Visual Analog Scale (VAS) for pain, Numeric Rating Scale (NRS), Quality of Life Scale (SF-36), Roland-Morris Disability Questionnaire, Oswestry Disability Index, Finger-to-Floor Distance Measurement, Beck Depression Inventory, and Lumbar Schober Test.
Patients will be divided into two groups. The first group will receive a home exercise program including lumbar active range of motion exercises and lumbar isometric strengthening exercises, performed five times per week for three weeks according to the level of movement restriction and pain severity, along with TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
The second group will receive the same home exercise program-including lumbar active range of motion exercises and lumbar isometric strengthening exercises-performed five times per week for three weeks according to the level of movement restriction and pain severity, along with sham TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having low back pain lasting longer than 12 weeks
- •Having a diagnosis of lumbar disc herniation (bulging, protruded, or extruded)
- •Being able to comply with the exercise program
- •Willingness to participate in the study Being between 20 and 60 years of age
排除标准
- •Being younger than 20 years or older than 60 years
- •Having a known and/or newly diagnosed malignancy
- •Presence of cardiac implants such as a pacemaker
- •Having inflammatory low back pain
- •Having absolute spinal stenosis (anteroposterior diameter of the spinal canal \< 10 mm and anteroposterior diameter of the lateral recess \< 3 mm)
- •History of surgery due to lumbar disc herniation, lumbar spinal stenosis, vertebral fracture, or similar conditions
- •Presence of lumbar spondylolisthesis
- •Patients with sequestered disc herniation
- •Patients with polyneuropathy
- •Patients with central pain following stroke
研究组 & 干预措施
TECAR Therapy
Patients with lumbar disc herniation
干预措施: TECAR THERAPY (Device)
sham TECAR Therapy
Patients with lumbar disc herniation
干预措施: TECAR Therapy (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Up to 1 month after the end of treatment
Zero indicates no pain at all, whereas ten represents the most severe pain imaginable.
次要结局
- Oswestry Disability Index(Up to 1 month after the end of treatment)
研究者
Cemre Saymaz
DOCTOR
Ankara City Hospital Bilkent