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

2026년 6월 8일 업데이트: Nguyen Hoang Ny, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluation of the Efficacy of the "Three-Needle Dazhui" Technique Combined With Electroacupuncture in Managing Pain and Improving Neck Disability in 74 Patients With Cervical Spondylotic Radiculopathy and Wind-Cold Syndrome: A Randomized, Single-Blind, Controlled 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

74

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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:

    1. Osteophytes (bone spurs) on the vertebral body.
    2. Intervertebral disc space narrowing ≥ 25%.
    3. Subchondral bone sclerosis.
    4. 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 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Standard Electroacupuncture + Standard care
The active comparator arm receives standard electroacupuncture treatment and standard care for 14 consecutive days.
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).
실험적: Three-Needle Dazhui" Technique Combined with Electroacupuncture + Standard care
Experimental arm receives the specialized "Three-Needle Dazhui" technique combined with electroacupuncture and standard care for 14 consecutive days.

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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Visual Analog Scale (VAS) Score
기간: Baseline (T0), 1 week (T1), and 2 weeks (T2).
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).

2차 결과 측정

결과 측정
측정값 설명
기간
Neck Disability Index (NDI) Score
기간: Baseline (T0), 1 week (T1), and 2 weeks (T2).
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.
Baseline (T0), 1 week (T1), and 2 weeks (T2).
Safety and Adverse Events
기간: From the first treatment session up to the completion of the 14th treatment session (approximately 2 weeks)

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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 8일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared outside the research team to ensure participant confidentiality.

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미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

목 통증에 대한 임상 시험

Standard Electroacupuncture + Standard care에 대한 임상 시험

구독하다