An interventional study of High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) and Pulsed Electromagnetic Field Therapy in Cervical Spondylosis, Neck Pain and Cervical Spondylotic Radiculopathy, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
This study is designed as a prospective, randomized, single-blind, parallel-group controlled trial. A total of 104 patients diagnosed with cervical spondylotic radiculopathy caused by cervical spondylosis will be recruited and randomly assigned in a 1:1 ratio into two groups using a computer-generated randomization sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.
Experimental Group: Patients will receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy.
Active Comparator Group: Patients will receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy.
Treatment Procedure:
Data Collection and Evaluation:
Outcome measures will be assessed at three predefined time points:
The primary and secondary outcomes include:
Pain intensity: Measured using the Visual Analog Scale (VAS). Cervical range of motion: Measured using a cervical goniometer. Functional disability: Measured using the Neck Disability Index (NDI). Safety: Recording treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, allergic reactions, infection, and other intervention-related adverse events throughout the study period.
To ensure objectivity, outcome assessments will be conducted by blinded physicians who are not involved in participant recruitment, treatment administration, or randomization. During data entry and statistical analysis, treatment allocation will be coded as Group A and Group B to minimize assessment bias. Statistical analyses will be performed using Generalized Estimating Equations (GEE), with statistical significance defined as a two-sided P value \<0.05.
Exclusion Criteria:
Participants receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions).
Procedure: High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) · Device: Pulsed Electromagnetic Field Therapy
Participants receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions).
Device: Pulsed Electromagnetic Field Therapy · Procedure: Conventional High-Frequency Electroacupuncture
High-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 (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
High-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.
Time frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
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.
Time frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
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.
Time frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
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.
Time frame: From the first treatment session until Day 14
Plan to share: No — Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.
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University of Medicine and Pharmacy at Ho Chi Minh City