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NCT07640126
Efficacy of Three-Needle Dazhui and Electroacupuncture for Cervical Spondylosis With Wind-Cold Syndrome
Conditions: Cervical Spondylosis, Wind-Cold Syndrome, Neck Pain, Cervical Spondylotic Radiculopathy
Sex: All
Ages: 18 Days – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 74
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Location: University of Medicine and Pharmacy at Ho Chi Minh City Ho Chi Minh City
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.
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:
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 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.
Source: ClinicalTrials.gov (NCT07640126). StuddyBuddy aggregates publicly available trial information.