Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy Of Jin's Three-Needle Technique Combined With Electroacupuncture In Cervical Spondylosis With Blood Stasis Syndrome

3. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhed: Electroacupuncture
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.
Adfærdsmæssigt: Active Movement Exercises
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.
Eksperimentel: 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.
Enhed: Electroacupuncture
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.
Adfærdsmæssigt: Active Movement Exercises
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.
Enhed: Jin's Three-Needle Acupuncture therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1. The change of the Visual Analog Scale (VAS)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in the Questionnaire Douleur Saint Antoine (QDSA) score
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change in the active range of motion of the cervical spine
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 497/HDDD-DHYD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Burundi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner