Transcutaneous Electrical Nerve Stimulation Versus Repetitive Transcranial Magnetic Stimulation on Pain and Functional Outcome in Cervical Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- pain intensity
研究概览
简要总结
this study will be conducted to compare between transcutaneous electrical nerve stimulation versus repetitive transcranial magnetic stimulation on pain and functional outcome in cervical radiculopathy
详细描述
Cervical Radiculopathy mostly occurs due to mechanical or inflammatory stimuli around the cervical nerve roots which is either due to disc herniation or osteophytes formation causing nerve root compression, inflammation or both but sometimes It can also be caused due to tumors, trauma, synovial cysts, meningeal cysts, dural arteriovenous fistula or tortous vertebral arteries.Transcutaneous electrical nerve stimulation (TENS) is a type of electrical stimulation which mostly aims for the symptomatic pain relief by stimulating the sensory nerve fibers either by pain gate mechanism or opioid system. As proposed by gate control theory, TENS produces an activation of inhibitory interneurons in the substantia gelatinosa in the dorsal horn of the spinal cord by the electric stimulation of large diameter fibres(A-beta -fibres), which inhibit the transmission of nociceptive signals from small diameter fibres (A delta and C) and as per opioid mechanism , it stimulates the release of endorphin, leading to vasodilation in the injured tissue.
Alternative non-pharmacological interventions using neuromodulation techniques have been proposed. Among them, repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) is the neuromodulation technique with the highest level of evidence, in the third- line treatment, to alleviate chronic neuropathic pain.
Owing to the limitations of current interventions, researchers are investigating the use of noninvasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), in chronic pain management. rTMS holds promise because of its ability to modulate cortical activity, which in turn can help manage chronic pain. High-frequency rTMS applied to the motor cortex contralateral to the side of the worst pain has been shown to be effective in inducing analgesia (pain relief) in various pain conditions including fibromyalgia, neuropathic pain, migraine, and chronic low back pain (CLBP) .Therefore, the purpose of this study was to evaluate whether targeting both the central (via rTMS) and the peripheral nervous system (via TENS) leads to increased pain relief, decreased functional disability, and improved quality of life compared with targeting both the peripheral and central nervous system in patients with cervical radiculopathy.
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)
盲法说明
opaque sealed envelope
入排标准
- 年龄范围
- 30 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients will be from both sexes, aged between (30 to 45) years
- •patients will be diagnosed as cervical radiculopathy unilateral upper limb pain radiating in C5,6 and C6,7 in the lateral aspect of the arm, forearm and hand for at least 3 months sensory in nature. (Sharma et al., 2025).
- •The Neck Disability Index (NDI) NDI more than 20%.
- •body mass index (BMI) was (18.5 to 29.9) Kg/m
- •Numeric Pain Rating Scale (NPRS) score > 6 y
排除标准
- •Patients with a history of injury to the cervical spine.
- •Patients who underwent cervicothoracic spine surgery, motor manifestations , spinal canal stenosis, bilateral symptoms, upper motor neuron impairments.
- •Use of steroids and pharmacological therapy.
- •Any congenital anomaly like cervical rib.
- •Pregnancy, oncological episodes.
- •The presence of a pacemaker, cochlear implant.
- •Epilepsy, psychotropic drug intake before admission, neurological disorders (such as stroke and plexopathies),
研究组 & 干预措施
Transcutaneous Electrical Nerve Stimulation
25 of cervical radiculopathy patients will participated in this group. They will receive peripheral nerve stimulation by using TENS (80-150ms) for 20 min. After that they will underwent the conventional physical therapy session for 3 days a week for 6 weeks
干预措施: Transcutaneous Electrical Nerve Stimulation (Other)
repetitive Transcranial Magnetic Stimulation
25 of cervical radiculopathy patients will participated in this group. They will receive cranial stimulation by using rtms 10 Hz frequency (90% rMT) for 20-minute duration (each trial includes 20 pulses in 2 seconds and 8 seconds intertrain interval). This process was repeated for three sessions in three consecutive days for 6 weeks
干预措施: repetitive Transcranial Magnetic Stimulation (Other)
结局指标
主要结局
pain intensity
时间窗: up to 6 weeks
it will be measured using neumerical pain rating scale (NPRS), There are 11 components in total, with a scoring range from 0 to 10, where 0 signifies the absence of pain, and 10 indicates the highest level of pain.
neck disability
时间窗: up to 6 weeks
it will be measured using Neck disability index. It consists of a series of questions related to various activities, and the patient rates their level of difficulty in performing each activity on a scale from 0 to 5 where grade 0 represents no to negligible symptoms and grade 5 represents severe symptoms. The total score will be then calculated and converted into a percentage with higher scores indicating greater disability and limitations due to neck pain. 0-20% indicates normal condition, 21-40% indicates mild disability, 41-60% indicates moderate disability, 61-80% indicates severe disability, and more than 80% indicates exaggerated dis ability.
sympathetic skin response
时间窗: up to 6 weeks
The sympathetic skin response is a measurement of the electrical potential generated by sweat glands in response to a stimulus, indicating sympathetic nervous system activity. SSR has been proposed as a non-invasive approach to investigate the function of the sympathetic system. it will be measured by electromyography device. Normal, resting adult values are commonly defined by a hand latency of 1.3-1.5 seconds, foot latency of 1.9-2.1 seconds, and an amplitude greater than 1 mV in the hand and 0.2 mV in the foot.
次要结局
- cervical range of motion(up to 6 weeks)
研究者
Rania Fathy Mustafa barseem
principle investigator : Rania fathy mustafa barseem
Cairo University
