Cervical spondylotic radiculopathy (CSR) is one of the most common manifestations of cervical spondylosis and is characterized by neck pain radiating to the upper extremities, sensory disturbances, restricted cervical range of motion, and functional disability. Conservative treatment is recommended as the first-line management for most patients, and electroacupuncture is widely used in Traditional Medicine to relieve pain and improve function.
Cervical Huatuo Jiaji (EX-B2) acupuncture points are anatomically located adjacent to the cervical spinal nerve roots and may provide more targeted therapeutic effects than conventional meridian acupuncture points. Pulsed electromagnetic field (PEMF) therapy has also been used as an adjunctive physical modality to reduce pain and facilitate functional recovery.
This randomized controlled trial aims to evaluate whether high-frequency electroacupuncture at cervical Huatuo Jiaji (EX-B2) points combined with PEMF therapy provides greater improvement in pain intensity, cervical function, and safety outcomes than conventional high-frequency electroacupuncture combined with PEMF therapy in patients with cervical spondylotic radiculopathy caused by cervical spondylosis.
The primary outcome is pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include cervical range of motion, Neck Disability Index (NDI), and treatment-related adverse events. Clinical outcomes will be assessed at baseline, after one week of treatment, and at the end of the two-week treatment period.
Written informed consent to participate in the study.
Male or female patients aged 30 years or older.
Inpatients or outpatients diagnosed with cervical spondylotic radiculopathy caused by cervical spondylosis at Ho Chi Minh City Hospital of Traditional Medicine.
Neck pain radiating to the shoulder and/or upper extremity.
Cervical radiculopathy caused by conditions other than cervical spondylosis.
Cervical myelopathy or other spinal cord disorders requiring surgical intervention.
Severe systemic illness, frailty, or medical conditions requiring intensive care, or suspected malignancy indicated by unexplained fever, unexplained weight loss, immunodeficiency, or cancer.
Contraindications to acupuncture, including skin infection or ulceration at the acupuncture site, allergy to acupuncture needles, severe needle phobia, or psychiatric disorders preventing cooperation.
Parallel
High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2)
Procedure/SurgeryHigh-frequency electroacupuncture (100 Hz) is applied to bilateral cervical Huatuo Jiaji (EX-B2) acupuncture points at the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments using standardized stimulation parameters.
Pulsed Electromagnetic Field Therapy
DevicePulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
Conventional High-Frequency Electroacupuncture
Procedure/SurgeryHigh-frequency electroacupuncture (100 Hz) is applied to conventional meridian acupuncture points on the affected side according to the standardized treatment protocol.
Change in neck pain intensity measured by the Visual Analog Scale (VAS)
Neck pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). Participants indicate their pain intensity by marking a point on a horizontal line anchored by "no pain" at 0 mm and "worst imaginable pain" at 100 mm. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a possible score ranging from 0 to 100 mm. Higher scores indicate greater pain intensity and therefore a worse outcome. Changes from baseline in the VAS score at Day 7 and Day 14 will be compared between the two treatment groups.
Change in functional disability measured by the Neck Disability Index (NDI)
Functional disability related to neck pain will be assessed using the 10-item Neck Disability Index (NDI). Each item is scored from 0 to 5, yielding a total score ranging from 0 to 50 points, where 0 indicates no disability and 50 indicates maximum disability. Higher scores indicate greater neck-related disability. Changes from baseline in the total NDI score at Day 7 and Day 14 will be compared between the two treatment groups.
Change in cervical range of motion (ROM)
Cervical range of motion (flexion, extension, lateral flexion, and rotation) will be measured using a cervical goniometer. Changes from baseline will be compared between the two treatment groups.
Treatment-related adverse events
Treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, infection, allergic reactions, and other intervention-related adverse events, will be recorded throughout the study.
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