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Recruiting 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.

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Source: ClinicalTrials.gov (NCT07640126). StuddyBuddy aggregates publicly available trial information.