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Cervical SpondylosisNCT07640126

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

A study testing Standard Electroacupuncture and Three-Needle Dazhui Technique & Electroacupuncture in people with Cervical Spondylosis and Wind-Cold Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 days and older
What is being tested?
Standard Electroacupuncture and Three-Needle Dazhui Technique & Electroacupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteVietnam
Study dates
1 Jun 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site, 1 recruiting
  • University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City

    Luu B Le, PhD, +84-857-323868, lebaoluu@ump.edu.vn

    Recruiting

Other trials in Vietnam

About this study

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

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.
Read the 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).
  3. 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.

Being tested
Standard Electroacupuncture, Three-Needle Dazhui Technique & Electroacupuncture, Standard Care Drugs
Medical subject headings
Spondylosis, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard ElectroacupunctureDevice

    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 & ElectroacupunctureDevice

    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 DrugsDrug

    Also called Phong te thap HD New, Paracetamol, Acetaminophen

    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).

Study groups in NCT07640126
Study groupRoleWhat they receive
Standard Electroacupuncture + Standard Care (Phong te thap HD New)Active comparatorThe active comparator arm receives standard electroacupuncture treatment and standard care for 14 consecutive days.
Receives: Device: Standard Electroacupuncture; Drug: Standard Care Drugs
Three-Needle Dazhui Technique & Electroacupuncture + Standard Care (Phong te thap HD New)ExperimentalExperimental arm receives the specialized "Three-Needle Dazhui" technique combined with electroacupuncture and standard care for 14 consecutive days.
Receives: Device: Three-Needle Dazhui Technique & Electroacupuncture; Drug: Standard Care Drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

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

Secondary outcomes (2)
  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.

    Measured: 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Randomized, Single-Blind, Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640126
Sponsor's protocol ID
7953/QĐ-ĐHYD
Other IDs
60.000.000 VNĐ
Status last verified
Jul 2026
First submitted
21 May 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the research team to ensure participant confidentiality.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29480409
  • 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.

    PubMed 32710604
  • 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.

    PubMed 21824580

Questions about this trial

What is this clinical trial studying?

A study testing Standard Electroacupuncture and Three-Needle Dazhui Technique & Electroacupuncture in people with Cervical Spondylosis and Wind-Cold Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) Score (time frame: Baseline (T0), 1 week (T1), and 2 weeks (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640126, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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