The Effect of Transcranial Magnetic Stimulation Therapy Combined With Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Low back and leg pain
研究概览
简要总结
The present study aims to investigate the efficacy of repetitive transcranial magnetic stimulation of the motor cortex combined with transforaminal epidural steroid injection in patients with chronic lumbar radiculopathy.
详细描述
Treatment methods of lumbar radiculopathy include short-term bed rest, medical treatments, physical therapy and rehabilitation techniques, psychotherapy, acupuncture, cryotherapy, epidural steroid injections, and surgical treatment. Epidural steroid injection is an effective treatment procedure in patients whose conservative treatment methods are not successful. Fluoroscopy guided transforaminal epidural steroid injection (TESI) is the most ideal procedure and it is considered as an effective treatment approach in radicular pain and concomitant neuropathic pain because of reaching the target area, which is the origin of pathology. Although radicular pain is usually caused by a peripheral lesion, central sensitization and maladaptive plasticity have been shown to play an important role in the development and chronicity of this pain. These data suggest that central pain processing should be altered or stopped, especially in the presence of refractory pain. Repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are non-invasive brain stimulation techniques that are increasingly being used to treat refractory neuropathic pain. Although short-term efficacy of rTMS treatment in radicular pain management was shown in one study, long-term efficacy was not evaluated and the necessity of trials evaluating long-term efficacy was reported. In accordance with these findings, we aimed to investigate the long-term effect of rTMS treatment in patients with chronic lumbar radiculopathy who received TESI.
Patients diagnosed with chronic lumbar radiculopathy and planned to administer fluoroscopy-guided TESI will be included in the study. Patients will be randomized into two groups following TESI. Home-based exercise program will be given to both groups after injection. One week after the injection, only the first group will receive 10 sessions of rTMS treatment for 2 weeks in addition to the exercise program. rTMS treatment will be performed with the device used in our clinic for neurological rehabilitation and pain management.
Patients will be assessed by a blind researcher using the Visual Analogue Scale (VAS) for low back and leg pain, the Douleur Neuropathique 4 Questions (DN-4) for neuropathic pain, the Oswestry Disability Index for disability, the Beck Depression Scale for depression, and the Central Sensitization Inventory for central sensitization. All assessments will be performed by the same physician before injection, first hour (only VAS), third week, third month, and sixth month after the injection. All adverse events will be noted.
After data collection, analysis will be performed with the appropriate statistical method.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20-60 years
- •Symptoms lasting longer than 3 months
- •To be planned TESI due to root compression which is caused by lumbar disk herniation
- •To agree to participate in the study
排除标准
- •Lumbar spinal stenosis
- •Presence of clinical findings incompatible with MRI
- •Spinal disease (trauma / tumor)
- •Spondylodiscitis or inflammatory spondylitis
- •Presence of epilepsy
- •Presence of implanted medical devices such as pacemakers, insulin pumps
- •Intracranial metallic implant
- •Previous cranial surgery history
- •Brain tumor
- •Severe hearing and vision loss
- •To be applied TESI for the last six months
- •Presence of surgical history through lumbar region
- •Spodilolistezis
- •Osteoporotic lumbar fracture
- •The presence of inflammatory diseases that affect spinal morphology, such as ankylosing spondylitis
- •Patients with electrophysiologically determined polyneuropathy, amyotrophic lateral sclerosis, etc. neurological disease
研究组 & 干预措施
Repetitive transcranial magnetic stimulation following TESI
Active repetitive transcranial magnetic stimulation will be performed to the patients with lumbar radiculopathy who receive transforaminal epidural steroid injection.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
Repetitive transcranial magnetic stimulation following TESI
Active repetitive transcranial magnetic stimulation will be performed to the patients with lumbar radiculopathy who receive transforaminal epidural steroid injection.
干预措施: Transforaminal epidural steroid injection (Drug)
Transforaminal epidural steroid injection
Transforaminal epidural steroid injection will be applied to the patients with lumbar radiculopathy.
干预措施: Transforaminal epidural steroid injection (Drug)
结局指标
主要结局
Low back and leg pain
时间窗: 6th month of treatment (T4)
Low back and leg pain will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no pain) to "10 cm" (intolerable pain).
次要结局
- Quality of life and activities of daily living(6th month of treatment (T3))
- Adverse events(6th month of treatment (T4))
- Central sensitization(6th month of treatment (T3))
- Neuropathic pain(6th month of treatment (T3))
- The Beck depression inventory(6th month of treatment (T3))