Efficacy Of Jin's Three-Needle Technique Combined With Electroacupuncture In Cervical Spondylosis With Blood Stasis Syndrome
3 maggio 2026 aggiornato da: Nguyen Nhu Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
The Potential Efficacy Of Jin's Three-Needle Technique Combined With Electroacupuncture In Managing Pain And Improving Cervical Active Range Of Motion In 104 Patients With Cervical Spondylosis And Blood Stasis Syndrome: A Randomized, Single-Blind, Controlled Trial
Neck pain is a highly prevalent condition, affecting 30% to 50% of the population, with cervical spondylosis accounting for up to 80% of these cases. The burden of cervical spondylosis continues to increase, leading to chronic mechanical pain, restricted mobility, and a significant socioeconomic impact. Treatment mainly includes non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, and traditional medicine therapies such as massage and acupuncture.
Jin's Three-Needle technique (specifically Cervical Three-Needle targeting Dazhu, Tianzhu, and Bailao acupoints) is a specialized acupuncture method created by Professor Jin Rui, demonstrating therapeutic effectiveness in improving local circulation and relieving neck pain. Recent studies have shown that acupuncture effectively manages pain in cervical spondylosis, especially for the Blood Stasis syndrome. Additionally, combining these specific acupoints with standard electroacupuncture and active movement exercises plays an essential role in alleviating pain and restoring cervical spine function. In practice, many practitioners apply Jin's Three-Needle technique to treat cervical spondylosis with considerable effectiveness, though it has not been thoroughly evidence-based in Vietnam for the Blood Stasis syndrome.
Given the limitations in evaluating treatment effectiveness and the lack of published research discussing the analgesic effects of Jin's Three-Needle technique for this specific syndrome in Vietnam , the investigators conducted the study to evaluate the pain reduction and range of motion improvement of Jin's Three-Needle technique combined with electroacupuncture in patients with cervical spondylosis with blood stasis syndrome.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
Patients with cervical spondylosis with blood stasis syndrome who have main symptoms such as mechanical neck pain, fixed pain points, and restricted cervical movement will be registered for this study. They will be randomly divided into two groups: the intervention group will be treated with a combination of Jin's Three-Needle technique (Dazhu, Tianzhu, Bailao) and standard electroacupuncture, while the control group will receive standard electroacupuncture alone. Both groups will be instructed to perform cervical active range of motion exercises at home.
The intervention period is two weeks. Acupuncture treatments will be performed five times a week (resting on weekends) for a total of 10 sessions. Data on the Visual Analog Scale (VAS), Questionnaire Douleur Saint Antoine (QDSA), active range of motion of the cervical spine, and side effects of the treatments (such as needle fainting or bleeding) will be recorded before the study (D0) and weekly for 2 weeks (D7 and D14).
Tipo di studio
Interventistico
Iscrizione (Stimato)
104
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Individuals between the ages of 18 and 70 years.
- Patients diagnosed with cervical spondylosis based on clinical symptoms (mechanical neck pain increasing with movement and decreasing at rest, continuous or episodic pain, restricted cervical movement) and subclinical criteria (at least one imaging evidence from X-ray or MRI showing cervical spondylosis).
- Patients diagnosed with Blood Stasis syndrome according to the 2002 Guidelines for Clinical Research of New Traditional Chinese Medicines. • Diagnosis requires >50% of the symptoms and at least one primary symptom. Primary symptoms include onset after neck trauma, stiff neck pain increasing with movement, and a fixed pain point. Secondary symptoms include limb numbness, pale pink or dark purple tongue with stasis spots, and a string-taut or choppy pulse.
- Individuals with an average pain score from 3 to less than 8 (3 ≤ VAS < 8) on the Visual Analogue Scale.
- Individuals who volunteered to participate in the study and signed a consent form.
Exclusion Criteria:
- Patients diagnosed with acute or chronic neck pain due to specific causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, disc herniation) or those having root compression syndrome, spinal cord compression syndrome, or vertebral artery syndrome.
- Patients with a history of neck trauma, cervical spine fracture or surgery, congenital spinal abnormalities, or systemic bone and joint diseases.
- Patients who have used medications affecting the study results within 1 week prior, including painkillers (Paracetamol, Tramadol, NSAIDs, Gabapentin, Pregabalin), muscle relaxants (Eperisone, Tolperisone), or traditional medicine for neck pain.
- Patients with contraindications to electroacupuncture according to the Ministry of Health guidelines, such as cachexia, decreased resistance, pregnancy, skin infection or ulceration at acupoints, prolonged fever, dehydration, blood loss, emergency conditions, heart failure, arrhythmia, or surgical causes of neck pain.
- Patients with mental illness or who are not fully conscious.
- Patients with a pacemaker or metal devices such as nails or splints.
- Patients currently using anticoagulants or having hemophilia.
- Patients currently participating in another interventional study
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
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 |
|---|---|
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Comparatore attivo: Electroacupuncture + Active Movement Exercises
Electroacupuncture performed once a day, five times a week for a total of two weeks (10 sessions).
Active cervical movement exercises performed two times a day for a total of two weeks.
|
Electroacupuncture will be performed once a day, five days a week for 2 weeks.
The acupoints treated are Jiaji C4-C7, Jianjing, Lieque, and Houxi.
Stimulation uses a continuous wave at 50 Hz, retained for 20 minutes.
Patients perform cervical active range of motion exercises at home.
Each exercise is performed 5 times per session, 2 sessions a day, with each session lasting about 20 minutes, for 2 weeks.
|
|
Sperimentale: Jin's Three-Needle Technique + Electroacupuncture + Active Movement Exercises
Jin's Three-Needle Technique and Electroacupuncture performed once a day, five times a week for a total of two weeks (10 sessions).
Active cervical movement exercises performed two times a day for a total of two weeks.
|
Electroacupuncture will be performed once a day, five days a week for 2 weeks.
The acupoints treated are Jiaji C4-C7, Jianjing, Lieque, and Houxi.
Stimulation uses a continuous wave at 50 Hz, retained for 20 minutes.
Patients perform cervical active range of motion exercises at home.
Each exercise is performed 5 times per session, 2 sessions a day, with each session lasting about 20 minutes, for 2 weeks.
Acupuncture therapy will be performed once a day, five days a week for 2 weeks.
The acupoints treated with this technique are Dazhu, Tianzhu, and Bailao.
Needles are retained for 20 minutes per session.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
1. The change of the Visual Analog Scale (VAS)
Lasso di tempo: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14).
|
Symptom scores will be assessed based on a visual analogue scale (VAS).
It usually consists of a 10 cm line anchored at each end by descriptors.
Patients will be classified into 1 of 4 groups (no pain (0 cm), mild pain (1-3 cm), moderate pain (4-7 cm), severe pain (8-10 cm)).
|
Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The change in the Questionnaire Douleur Saint Antoine (QDSA) score
Lasso di tempo: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14)
|
The QDSA is a multi-dimensional pain assessment tool that evaluates the sensory, emotional, cognitive, and behavioral components of pain.
The total score ranges from 0 to 64.
The percentage of pain reduction based on the QDSA score will be calculated and categorized into four levels: Good (>75%), Fair (50%-75%), Average (25%-49%), and Poor (<25%).
|
Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The change in the active range of motion of the cervical spine
Lasso di tempo: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14)
|
The active range of motion of the cervical spine will be measured using a goniometer.
The movements assessed include flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation.
The degree of limitation will be scored from 0 (no limitation) to 4 (severe limitation) based on physiological norms.
|
Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Yen CM, Wu TC, Hsieh CL, Huang YW, Lin YW. Distal Electroacupuncture at the LI4 Acupoint Reduces CFA-Induced Inflammatory Pain via the Brain TRPV1 Signaling Pathway. Int J Mol Sci. 2019 Sep 10;20(18):4471. doi: 10.3390/ijms20184471.
- Jiang M, Chen X, Zhang L, Liu W, Yu X, Wang Z, Zheng M. Electroacupuncture suppresses glucose metabolism and GLUT-3 expression in medial prefrontal cortical in rats with neuropathic pain. Biol Res. 2021 Aug 6;54(1):24. doi: 10.1186/s40659-021-00348-0.
- Eslamian F, Jahanjoo F, Dolatkhah N, Pishgahi A, Pirani A. Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2020 May;101(5):770-780. doi: 10.1016/j.apmr.2019.12.009. Epub 2020 Jan 16.
- Wilhelm M, Cleland J, Carroll A, Marinch M, Imhoff M, Severini N, Donaldson M. The combined effects of manual therapy and exercise on pain and related disability for individuals with nonspecific neck pain: A systematic review with meta-analysis. J Man Manip Ther. 2023 Dec;31(6):393-407. doi: 10.1080/10669817.2023.2202895. Epub 2023 Apr 24.
- Yu ML, Wei RD, Zhang T, Wang JM, Cheng Y, Qin FF, Fu SP, Lu ZG, Lu SF. Electroacupuncture Relieves Pain and Attenuates Inflammation Progression Through Inducing IL-10 Production in CFA-Induced Mice. Inflammation. 2020 Aug;43(4):1233-1245. doi: 10.1007/s10753-020-01203-2.
- 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.
- Lin W, Chen XL, Chen Q, Wen J, Chen X. Jin's three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial. Trials. 2019 Mar 4;20(1):155. doi: 10.1186/s13063-019-3243-5.
- Liao W, Tang C, Zhang J. [Discussion on the principle and treatment pathway of Jin's three-needle technique for mind regulation and treatment from the "adjusting qi to regulate mind, adjusting blood to regulate mind"]. Zhongguo Zhen Jiu. 2018 Nov 12;38(11):1235-8. doi: 10.13703/j.0255-2930.2018.11.027. Chinese.
- Fu WB, Liang ZH, Zhu XP, Yu P, Zhang JF. Analysis on the effect of acupuncture in treating cervical spondylosis with different syndrome types. Chin J Integr Med. 2009 Dec;15(6):426-30. doi: 10.1007/s11655-009-0426-z. Epub 2010 Jan 18.
- Plastaras CT, Schran S, Kim N, Sorosky S, Darr D, Chen MS, Lansky R. Complementary and alternative treatment for neck pain: chiropractic, acupuncture, TENS, massage, yoga, Tai Chi, and Feldenkrais. Phys Med Rehabil Clin N Am. 2011 Aug;22(3):521-37, ix. doi: 10.1016/j.pmr.2011.02.011.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 maggio 2026
Completamento primario (Stimato)
1 ottobre 2026
Completamento dello studio (Stimato)
1 ottobre 2026
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Terapie
- Terapie complementari
- Modalità di terapia fisica
- Riabilitazione
- Anestesia e analgesia
- Terapia di stimolazione elettrica
- Terapia di modalità combinata
- Anestesia
- Analgesia
- Terapia di agopuntura
- Stimolazione del nervo elettrico transcutaneo
- Elettroacopuntura
Altri numeri di identificazione dello studio
- 497/HDDD-DHYD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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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