- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07557511
Transcutaneous Electrical Nerve Stimulation Versus Repetitive Transcranial Magnetic Stimulation on Pain and Functional Outcome in Cervical Radiculopathy (CR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: rania barseem, master
- Phone Number: 01068207592
- Email: raniafathy141986@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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/m2.
- Numeric Pain Rating Scale (NPRS) score > 6 y
Exclusion Criteria:
- 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),
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
patients will receive TENS to relieve peripheral radiating pain, with high frequency (80 Hz), low intensity (as per the patient's comfort but will not be painful and not elicit the muscle contraction) and a pulse width of 150 µs of asymmetrical biphasic rectangular waveforms, will be used for 20 min+ cinventional therapy in the form of Moist Heat followed by cervical traction in a seated position manually followed by nerve glides and Chin Tuck exercises
|
|
Experimental: 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
|
Participants will be seated in an rTMS chair with a head and armrest.
The resting motor threshold (rTMS) will be defined using visual observation of muscle twitch , For this method, rTMS Applied at Primary Motor Cortex (M1): The stimulation is applied over the M1 region contralateral to the side of pain.
Frequency: High-frequency rTMS, typically at 10 Hz, is employed to enhance cortical excitability.
the patient's hand will be placed on the armrest and rMT will be set as the lowest setting at which ≥10 of 20 stimuli resulted in any observable contraction of the right thumb (abductor pollicis brevis [ABP]muscles).
The rTMS system was set on 10 Hz frequency (90% rMT), (900 pulses [45 trials] were delivered to the right motor cortex [position C4] or 900 pulses [45 trials] were delivered to the left motor cortex [position C3]), and 20-minute duration (each trial includes 20 pulses in 2 seconds and 8 seconds.plus
conventional therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: 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.
|
up to 6 weeks
|
|
neck disability
Time Frame: 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.
|
up to 6 weeks
|
|
sympathetic skin response
Time Frame: 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.
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical range of motion
Time Frame: up to 6 weeks
|
cervical range of motion device will be used to assess cervical range of motion
|
up to 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Radiculopathy
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Magnetic Field Therapy
- Electric Stimulation Therapy
- Analgesia
- Transcranial Magnetic Stimulation
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- P.T.REC/012/006350
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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