BridgeMD
Tests treatment safety and results for Cervical Spondylosis
Official title Efficacy of Three-Needle Dazhui and Electroacupuncture for Cervical Spondylosis With Wind-Cold Syndrome
ClinicalTrials.gov ID: NCT07640126
What this study is testing
What is Standard Care Drugs?
Standard Care Drugs is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cervical spondylosis.
Also referred to as Phong te thap HD New, Paracetamol, Acetaminophen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Cervical Spine Syndrome: Localized neck pain, restricted range of motion, and tenderness upon palpation of the spinous processes or paravertebral...
You likely can't join if
- History of neck trauma.
- Diagnosed with specific bone or joint diseases: Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Down syndrome, cervical spina...
- 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...
- Central motor neuron lesions: Presence of Hoffmann's sign, Babinski's sign, hyperreflexia, spasticity, urinary/fecal incontinence, or sexual...
See the full eligibility 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...
- 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.
- 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...
- Other ongoing treatments: Currently undergoing other therapies such as acupressure, massage, or physical therapy for the neck area.
The study team makes the final eligibility decision.
Where it's taking place
- Ho Chi Minh City, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ho Chi Minh City, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.