Efficacy of the "Three-Needle Dazhui" Technique Combined With Electroacupuncture for Cervical Spondylosis With Wind-Cold Syndrome

NCT07640126 | Not Yet Recruiting

• 1 other identifier: 499/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Spondylosis; Wind-Cold Syndrome; Neck Pain; Cervical Spondylotic Radiculopathy

Outcome Measures

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".

  Baseline (T0), 1 week (T1), and 2 weeks (T2).

Secondary Outcomes (2)

• Neck Disability Index (NDI) Score

  Baseline (T0), 1 week (T1), and 2 weeks (T2).

• Safety and Adverse Events

  From the first treatment session up to the completion of the 14th treatment session (approximately 2 weeks)

Study Arms (2)

Standard Electroacupuncture + Standard care

ACTIVE COMPARATOR

The active comparator arm receives standard electroacupuncture treatment and standard care for 14 consecutive days.

Device: Standard Electroacupuncture + Standard care; Drug: Standard Electroacupuncture + Standard care

Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care

EXPERIMENTAL

Experimental arm receives the specialized "Three-Needle Dazhui" technique combined with electroacupuncture and standard care for 14 consecutive days.

Device: Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care; Drug: Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care

Interventions

Standard Electroacupuncture + Standard care 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.

Standard Electroacupuncture + Standard care

Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care 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.

Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care

Eligibility Criteria

• Age: 18 Days+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 motor or sensory radicular disorders: Muscle weakness or sensory disturbances such as burning, tingling, or numbness in the shoulder, arm, or hand.
• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Mansfield M, Smith T, Spahr N, Thacker M. Cervical spine radiculopathy epidemiology: A systematic review. Musculoskeletal Care. 2020 Dec;18(4):555-567. doi: 10.1002/msc.1498. Epub 2020 Jul 25.

  PMID: 32710604 BACKGROUND

• Bogduk N. The anatomy and pathophysiology of neck pain. Phys Med Rehabil Clin N Am. 2011 Aug;22(3):367-82, vii. doi: 10.1016/j.pmr.2011.03.008.

  PMID: 21824580 RESULT

MeSH Terms

Conditions

Spondylosis; Neck Pain

Interventions

Standard of Care; Electroacupuncture

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share