- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07640126
Efficacy of the "Three-Needle Dazhui" Technique Combined With Electroacupuncture for Cervical Spondylosis With Wind-Cold Syndrome
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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:
- Pain Intensity: Measured by the Visual Analog Scale (VAS).
- 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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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:
- 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.
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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).
|
|
Sperimentale: 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).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Visual Analog Scale (VAS) Score
Lasso di tempo: 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).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Neck Disability Index (NDI) Score
Lasso di tempo: 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).
|
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Safety and Adverse Events
Lasso di tempo: 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:
|
From the first treatment session up to the completion of the 14th treatment session (approximately 2 weeks)
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie ossee
- Malattie muscoloscheletriche
- Malattie della colonna vertebrale
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Spondilosi
- Dolore al collo
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Terapie
- Qualità dell'assistenza sanitaria
- Terapie complementari
- Modalità di terapia fisica
- Indicatori di qualità, assistenza sanitaria
- Riabilitazione
- Anestesia e analgesia
- Terapia di stimolazione elettrica
- Terapia di modalità combinata
- Anestesia
- Analgesia
- Terapia di agopuntura
- Stimolazione del nervo elettrico transcutaneo
- Standard di cura
- Elettroacopuntura
Altri numeri di identificazione dello studio
- 499/ĐHYD-HĐĐĐ
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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