Transcutaneous Electrical Nerve Stimulation Versus Repetitive Transcranial Magnetic Stimulation on Pain and Functional Outcome in Cervical Radiculopathy

Overview

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

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.

Interventions

• Other Transcutaneous Electrical Nerve Stimulation
  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
• Other repetitive Transcranial Magnetic Stimulation
  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 wh

Primary outcome measures

• pain intensity [Time frame: up to 6 weeks]
• neck disability [Time frame: up to 6 weeks]
• sympathetic skin response [Time frame: up to 6 weeks]

Secondary outcome measures (1)

• cervical range of motion [Time frame: up to 6 weeks]

Eligibility criteria

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),

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07557511 · P.T.REC/012/006350

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗