Authors
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University of Medicine and Pharmacy at Ho Chi Minh City -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
This study is designed as a prospective, randomized, single‐blind, parallel‐groupcontrolled trial. A total of 104 patients diagnosed with cervical spondyloticradiculopathy caused by cervical spondylosis will be recruited and randomly assigned in a1:1 ratio into two groups using a computer‐generated randomization sequence. Allocationconcealment will be ensured using sequentially numbered, opaque, sealed envelopes.Experimental Group: Patients will receive high‐frequency electroacupuncture (100 Hz) atbilateral 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 samepulsed electromagnetic field (PEMF) therapy.Treatment Procedure: ‐ A total of 104 participants will be enrolled, with 52 participants allocated to eachstudy group. ‐ Both groups will receive one treatment session daily, Monday through Friday, for twoconsecutive weeks (10 treatment sessions). Each electroacupuncture session will lastapproximately 20 minutes. ‐ All interventions will be performed according to standardized treatment protocols bylicensed Traditional Medicine physicians who have received protocol‐specifictraining before study initiation. ‐ No additional acupuncture interventions outside the study protocol will be permittedduring the study period.Data Collection and Evaluation:Outcome measures will be assessed at three predefined time points: ‐ N0: Baseline (before treatment) ‐ N7: After one week of treatment ‐ N14: End of the two‐week treatment periodThe 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 NeckDisability Index (NDI). Safety: Recording treatment‐related adverse events, includingbleeding, 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 whoare not involved in participant recruitment, treatment administration, or randomization.During data entry and statistical analysis, treatment allocation will be coded as Group Aand Group B to minimize assessment bias. Statistical analyses will be performed usingGeneralized Estimating Equations (GEE), with statistical significance defined as atwo‐sided P value <0.05.
Epistemonikos ID: 6f7860c9eda4a27b7f0c1e2364135ef3ab0343d3
First added on: Jul 18, 2026