Effect of Repetative Transcranial Magnetic Stimulation Therapy on Neuropathic Pain in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline Visual Analog Scale (VAS) at 15 day and 6 week.
研究概览
简要总结
The aim of our study is to investigate the effect of high-frequency Repetitive Transcranial Magnetic Stimulation(rTMS) therapy applied to the dorsolateral PFC (DLPFC) area on neuropathic pain in patients with spinal cord injury. In this area, there are very few studies on the effectiveness of rTMS treatment added to medical treatment in neuropathic pain. In addition, the number of studies comparing the effect of rTMS therapy applied to the DLFPC area is very few.
详细描述
Spinal cord injury (SCI) is associated with widespread disability due to its detrimental effects on various bodily functions. Neuropathic pain is one of the most challenging complications after SCI and can have a significant impact on daily life.
There are supportive criteria for the diagnosis of neuropathic pain associated with SCI: onset of pain within one year after SCI, absence of primary association between pain with movement, inflammation or other local tissue damage, burning, tingling, pins and needles, throbbing pain, squeezing pain, Detection of 1 or more of the pain descriptors such as freezing pain, allodynia or hyperalgesia within the pain distribution support neuropathic pain due to spinal cord injury.
Pharmacological and interventional treatments are often tried in the treatment of neuropathic pain, but their success is often limited. Another option that has been used as an innovative approach in the treatment of neuropathic pain in recent years is pain regulation with rTMS. As one of the non-invasive brain stimulation techniques, rTMS is suggested to be useful in the treatment of central neuropathic pain. While most studies to date have mainly targeted the primary motor cortex (M1), which is contralateral to the pain side, fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral PFC (DLPFC). The analgesic mechanisms of rTMS to the DLPFC are thought to be through the same mechanism as stimulation of the M1 motor cortex.
The aim of our study; To investigate the effect of high frequency rTMS applications on patients with SCI on their neuropathic pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 20-70, who applied to the AFSU Physical Medicine and Rehabilitation inpatient service with the diagnosis of spinal cord injury and
- •Having spinal cord injury with neurophatic pain at least six months ago,
- •Able to follow two-stage verbal commands,
- •Agreeing to participate in the study voluntarily and regularly,
- •Patients who are medically stable (no previous myocardial infarction, no musculoskeletal problems) will be included in our study.
排除标准
- •Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- •Epilepsy,
- •History of antiepileptic drug use,
- •Intracranial metal object,
- •Presence of in-ear implant,
- •Cognitive dysfunction,
- •Lower extremity peripheral nerve injury,
- •With malignancy and active infection,
- •Infection on the skin in the application area,
- •Having an open wound,
- •Having inflammatory disease,
- •Orthopedic injuries that can limit maximum effort contractions,
- •Having a brain lesion or a history of drug use that will affect the seizure threshold,
- •Patients with increased intracranial pressure or uncontrolled migraine will not be included.
研究组 & 干预措施
High-frequency real-time rTMS protocol
It was planned to apply a total of 1200 beats to the dorsolateral prefrontal cortex daily at a frequency of 10 HZ at 110% intensity of the motor threshold for 15 sessions.
干预措施: High-frequency real-time rTMS protocol (Device)
Sham rTMS Protocol
It was planned to apply daily sham rTMS to the dorsolateral prefrontal cortex for 15 sessions.
干预措施: Sham rTMS Protocol (Device)
结局指标
主要结局
Change from baseline Visual Analog Scale (VAS) at 15 day and 6 week.
时间窗: up to 6 week
It is evaluated between 0-10. 10 means severe pain, 0 means no pain. Night and day VAS assessment will be questioned.
次要结局
- Change from baseline Short form McGill Pain questionnaire(SF-MPQ) at 15 day and 6 week.(up to 6 week)
- Change from baseline Short form 36 (SF-36) at 15 day and 6 week.(up to 6 week)
- Change from baseline The Leeds Assessment of Neuropathic Symptoms & Signs Pain Scale(LANSS) at 15 day and 6 week.(up to 6 week)
- Change from baseline Beck Depression Scale at 15 day and 6 week.(up to 6 week)
- Beck Anxiety Scale at 15 day and 6 week.(up to 6 week)
研究者
Nuran Eyvaz
Assistant Professor
Afyonkarahisar Health Sciences University