An interventional study of Standard Electroacupuncture and Three-Needle Dazhui Technique & Electroacupuncture in Cervical Spondylosis, Wind-Cold Syndrome and Neck Pain, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 18 Days and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
Cervical spondylosis is a prevalent health issue that significantly impacts quality of life, with Cervical Spondylotic Radiculopathy (CSR) accounting for 60-70% of cases
This study is designed as a randomized, single-blind, controlled trial. A total of 74 patients meeting the diagnostic criteria for cervical spondylotic radiculopathy with Wind-Cold syndrome will be recruited and randomly assigned into two groups using a block randomization method.
Treatment Procedure:
Data Collection and Evaluation: Outcome measures will be assessed at three time points: T0 (baseline), T1 (after 1 week), and T2 (after 2 weeks/end of treatment). The primary and secondary outcomes include:
2. Safety: Recording adverse events such as needle fainting, bleeding, or localized pain throughout the study period.
To ensure objectivity, evaluations will be conducted by blinded physicians who are not involved in the treatment or group allocation processes.
144 studies on the registry are indexed under Spondylosis; 41 are open to participants now.
This study's planned enrollment of 74 is above the median of 60 across 99 interventional studies indexed under Spondylosis.
Browse Spondylosis studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Modern Medicine Diagnosis (Cervical Spondylotic Radiculopathy - CSR) Patients must meet the diagnostic criteria for CSR due to cervical spondylosis according to Decision 361/QD-BYT, including:
Radicular Syndrome: Neck pain radiating to the occipital region, shoulder, arm, or hand.
Imaging Criteria: X-ray findings (straight, lateral, or 3/4 oblique views) showing at least one of the following:
Exclusion Criteria:
The active comparator arm receives standard electroacupuncture treatment and standard care for 14 consecutive days.
Device: Standard Electroacupuncture · Drug: Standard Care Drugs
Experimental arm receives the specialized "Three-Needle Dazhui" technique combined with electroacupuncture and standard care for 14 consecutive days.
Device: Three-Needle Dazhui Technique & Electroacupuncture · Drug: Standard Care Drugs
Participants receive 14 daily electroacupuncture sessions (20 min/session) using sterile 0.3 × 25 mm needles with De Qi stimulation. Acupoints include GB20, GB21, Ashi points, Jiaji (C4-C7), LI10, TE5, SI3, and LI4. Electrical stimulation is delivered at 100 Hz with intensity 0-4 mA according to patient tolerance. Negative (-) poles are connected to GB20, Ashi points, and TE5; positive (+) poles to GB21, LI10, and SI3.
Three sterile stainless steel needles (0.3 × 40 mm) are inserted at GV14 (Dazhui), located below the spinous process of the seventh cervical vertebra. One central needle is inserted vertically along the thoracic spine, while two lateral needles are inserted 5 mm to the left and right of the central needle and directed toward it at a 90° angle. Needles are initially inserted at 30°, then lowered to 15° to reach a depth of approximately 3 cm. Gentle manipulation is applied to obtain the "De Qi" sensation. Standard electroacupuncture is applied at Jiaji (C4-C7), GB20, GB21, LI10, TE5, SI3, LI4, and Ashi points. Electrical stimulation is delivered at 100 Hz with an intensity of 0-4 mA according to patient tolerance for 20 minutes daily. The negative (-) pole is connected to the GV14 site, and the positive (+) pole is connected to GB21.
Standard care: Phong te thap HD New (3 capsules twice daily), posture education, cervical exercises, and paracetamol 500 mg as rescue medication if VAS \>7 (max 3 tablets/day).
Also known as: Phong te thap HD New, Paracetamol, Acetaminophen
Visual Analog Scale (VAS) Score
A quantitative tool used to measure pain intensity on a scale from 0 to 10 points (or 0-100 mm). A score of 0 indicates "no pain," while 10 represents "unbearable pain".
Time frame: Baseline (T0), 1 week (T1), and 2 weeks (T2).
Neck Disability Index (NDI) Score
A standardized 10-item questionnaire used to evaluate the impact of neck pain on daily life. It includes categories such as personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, with a total maximum score of 50 points; higher scores indicate greater disability.
Time frame: Baseline (T0), 1 week (T1), and 2 weeks (T2).
Safety and Adverse Events
Monitoring for any side effects related to the acupuncture procedure. This includes: * Local reactions: Pain, swelling, bleeding, or infection at the needle site. * Systemic reactions (Needle Fainting/Vựng châm): Dizziness, nausea, cold limbs, cold sweat, or hypotension (systolic blood pressure \< 85 mmHg).
Time frame: From the first treatment session up to the completion of the 14th treatment session (approximately 2 weeks)
Plan to share: No — Individual participant data will not be shared outside the research team to ensure participant confidentiality.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Medicine and Pharmacy at Ho Chi Minh City