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

Official title

Three-Needle Dazhui Combined With Electroacupuncture for Cervical Spondylotic Radiculopathy and Wind-Cold Syndrome: A Randomized, Single-Blind, Controlled Trial Evaluating Pain and Neck Disability

Overview

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.

Detailed description

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.

Interventions

• Device Standard Electroacupuncture
  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.
• Device Three-Needle Dazhui Technique & Electroacupuncture
  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" se
• Drug Standard Care Drugs
  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).

Primary outcome measures

• Visual Analog Scale (VAS) Score [Time frame: Baseline (T0), 1 week (T1), and 2 weeks (T2).]

Secondary outcome measures (2)

• Neck Disability Index (NDI) Score [Time frame: Baseline (T0), 1 week (T1), and 2 weeks (T2).]
• Safety and Adverse Events [Time frame: From the first treatment session up to the completion of the 14th treatment session (approximately 2 weeks)]

Eligibility criteria

Inclusion criteria

• 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.
• 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:

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

Radicular Syndrome: Neck pain radiating to the occipital region, shoulder, arm, or hand.

• Physical Examination: At least one positive result from the following tests: Bell-ringer sign, Spurling's test, Shoulder abduction test, or Cervical distraction test.
• Imaging Criteria: X-ray findings (straight, lateral, or 3/4 oblique views) showing at least one of the following:

• Osteophytes (bone spurs) on the vertebral body.
• Intervertebral disc space narrowing ≥ 25%.
• Subchondral bone sclerosis.
• Spondylolisthesis. - Traditional Chinese Medicine (TCM) Diagnosis (Wind-Cold Syndrome) Patients must satisfy at least one primary symptom and reach a total symptom score of ≥ 50% based on the following criteria:
• Primary Symptoms: Pain in the neck and shoulder radiating to the arm accompanied by numbness; pain is the dominant feature; pain increases with cold and decreases with warmth.
• Secondary Symptoms: Aversion to cold, aversion to wind, cold extremities, and presence or absence of sweating.
• Tongue and Pulse: Pale tongue with a thin white coating; floating-tight or slow pulse.

Exclusion criteria

• 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.
• Autonomic nervous system disorders: Pain accompanied by tinnitus, visual disturbances, or vasomotor disorders in the occipital-shoulder region or arms.
• Central motor neuron lesions: Presence of Hoffmann's sign, Babinski's sign, hyperreflexia, spasticity, urinary/fecal incontinence, or sexual dysfunction.
• Symptoms suggesting systemic or malignant disease: Unexplained weight loss, fever, loss of appetite, personal or family history of malignant tumors, or diffuse pain and stiffness.
• Symptoms suggesting infection: Fever, meningeal signs, or photophobia.
• Symptoms suggesting serious acute medical conditions: Myocardial infarction (chest pain + sweating + shortness of breath) or arterial dissection (tearing pain sensation + headache + blurred vision).
• Local or systemic contraindications: Infection or ulceration at the acupuncture site; patients who are exhausted, emaciated, or suffering from severe accompanying internal medical diseases.
• Substance abuse: Alcohol or drug addiction.
• Recent medication use (within the past month): Currently using analgesics or anti-inflammatory drugs that may affect results, such as Opioids, NSAIDs, Corticosteroids, Gabapentin, Pregabalin, or tricyclic antidepressants.
• Other ongoing treatments: Currently undergoing other therapies such as acupressure, massage, or physical therapy for the neck area.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Publications

• Ofiram E, Garvey TA, Schwender JD, Denis F, Perra JH, Transfeldt EE, Winter RB, Wroblewski JM. Cervical degenerative index: a new quantitative radiographic scoring system for cervical spondylosis with interobserver and intraobserver reliability testing. J Orthop Traumatol. 2009 Mar;10(1):21-6. doi: 10.1007/s10195-008-0041-3. Epub 2009 Feb 3. PMID 19384631
• Seo SY, Lee KB, Shin JS, Lee J, Kim MR, Ha IH, Ko Y, Lee YJ. Effectiveness of Acupuncture and Electroacupuncture for Chronic Neck Pain: A Systematic Review and Meta-Analysis. Am J Chin Med. 2017;45(8):1573-1595. doi: 10.1142/S0192415X17500859. Epub 2017 Nov 9. PMID 29121797
• Lv ZT, Shen LL, Zhu B, Zhang ZQ, Ma CY, Huang GF, Yin J, Yu LL, Yu SY, Ding MQ, Li J, Yuan XC, He W, Jing XH, Li M. Effects of intensity of electroacupuncture on chronic pain in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Res Ther. 2019 May 14;21(1):120. doi: 10.1186/s13075-019-1899-6. PMID 31088511
• Bakhsheshian J, Mehta VA, Liu JC. Current Diagnosis and Management of Cervical Spondylotic Myelopathy. Global Spine J. 2017 Sep;7(6):572-586. doi: 10.1177/2192568217699208. Epub 2017 May 31. PMID 28894688
• Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302. PMID 28666405
• Nurmesa A, Zakiyah N, Insani WN. Clinical Presentations and Characteristics of NSAIDs Hypersensitivity in a Tertiary Care Hospital in Indonesia: A Case Series. Int Med Case Rep J. 2025 Jan 25;18:163-171. doi: 10.2147/IMCRJ.S488796. eCollection 2025. PMID 39881781
• Yang F, Li WX, Liu Z, Liu L. Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial. Trials. 2016 Oct 22;17(1):513. doi: 10.1186/s13063-016-1644-2. PMID 27770801
• Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26. PMID 29480409

Identifiers

NCT: NCT07640126 · 7953/QĐ-ĐHYD · 60.000.000 VNĐ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗