Efficacy of Three-Needle Dazhui and Electroacupuncture for Cervical Spondylosis With Wind-Cold Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consent: Participants must voluntarily agree to participate and sign a written informed consent form.

Age: Individuals aged 18 years or older.

Pain Intensity: Patients with a baseline pain score of VAS ≥ 50 mm on the Visual Analog Scale.

Cervical Spine Syndrome: Localized neck pain, restricted range of motion, and tenderness upon palpation of the spinous processes or paravertebral areas.

Disqualifiers

History of neck trauma.

Diagnosed with specific bone or joint diseases: Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Down syndrome, cervical spina bifida, or Scheuermann's disease.

Severe neurological deficits: Progressive muscle weakness (motor loss) or acute, severe sensory loss indicating advanced nerve compression.

Vertebral-basilar artery syndrome: Headache, dizziness, tinnitus, loss of balance, or fatigue.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Electroacupuncture

    Device

    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-Needle Dazhui Technique & Electroacupuncture

    Device

    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 Drugs

    Drug

    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).

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Standard Electroacupuncture + Standard Care (Phong te thap HD New)Active comparator 2 interventions
Group B: Three-Needle Dazhui Technique & Electroacupuncture + Standard Care (Phong te thap HD New)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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)

Other outcomes

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