Cervical spondylosis is a prevalent health issue that significantly impacts quality of life, with Cervical Spondylotic Radiculopathy (CSR) accounting for 60-70% of cases * While modern medicine offers various treatments, the frequent use of painkillers often leads to undesirable side effects * In Traditional Chinese Medicine, electroacupuncture is a safe and effective method recognized by the Ministry of Health for treating this condition * The "Three-Needle Dazhui" technique is a specialized acupuncture method that simultaneously uses three needles at the Dazhui (GV14) point to strongly activate Yang Qi and dispel cold, making it particularly suitable for the Wind-Cold syndrome. This study aims to evaluate whether the combination of the Three-Needle Dazhui technique and electroacupuncture yields better results in pain reduction and functional improvement compared to electroacupuncture alone in patients with cervical spondylosis and Wind-Cold syndrome.
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. * Intervention Group: Patients will receive the "Three-Needle Dazhui" technique (using three needles at specific angles and depths at the Dazhui point) combined with the standard electroacupuncture protocol authorized by the Ministry of Health and basic treatment. * Control Group: Patients will receive only the standard electroacupuncture protocol and basic treatment. Treatment Procedure: * Both groups will undergo treatment for 14 consecutive days, with one 20-minute session per day. * Basic treatment includes the administration of traditional herbal medicine (Phong te thap HD New) and education on proper posture and cervical spine exercises. * Paracetamol (500mg) will be provided only for acute, high-intensity pain (VAS \> 7/10). 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: 1. Pain Intensity: Measured by the Visual Analog Scale (VAS). 2. Functional Movement: Measured by the Neck Disability Index (NDI). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
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.
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).
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).
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)
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