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

NCT07559279 | Not Yet Recruiting

• 1 other identifier: 497/HDDD-DHYD
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 1. The change of the Visual Analog Scale (VAS)

  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), after 1 week of intervention (D7), and after 2 weeks of intervention (D14).

Secondary Outcomes (1)

• The change in the Questionnaire Douleur Saint Antoine (QDSA) score

  Assessments will be conducted before the intervention (D0), after 1 week of intervention (D7), and after 2 weeks of intervention (D14)

Other Outcomes (1)

• The change in the active range of motion of the cervical spine

  Assessments will be conducted before the intervention (D0), after 1 week of intervention (D7), and after 2 weeks of intervention (D14)

Study Arms (2)

Electroacupuncture + Active Movement Exercises

ACTIVE COMPARATOR

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.

Other: Electroacupuncture; Other: Active Movement Exercises

Jin's Three-Needle Technique + Electroacupuncture + Active Movement Exercises

EXPERIMENTAL

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.

Other: Jin's Three-Needle Technique; Other: Electroacupuncture; Other: Active Movement Exercises

Interventions

Jin's Three-Needle Technique OTHER

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.

Jin's Three-Needle Technique + Electroacupuncture + Active Movement Exercises

Electroacupuncture OTHER

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.

Electroacupuncture + Active Movement Exercises; Jin's Three-Needle Technique + Electroacupuncture + Active Movement Exercises

Active Movement Exercises OTHER

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.

Electroacupuncture + Active Movement Exercises; Jin's Three-Needle Technique + Electroacupuncture + Active Movement Exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Related Publications (10)

• 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.

  PMID: 31510092 BACKGROUND

• 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.

  PMID: 34362470 BACKGROUND

• 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.

  PMID: 31954696 BACKGROUND

• 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.

  PMID: 37092822 BACKGROUND

• 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.

  PMID: 32198725 BACKGROUND

• 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.

  PMID: 19384631 BACKGROUND

• 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.

  PMID: 30832713 BACKGROUND

• 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.

  PMID: 30672207 BACKGROUND

• 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.

  PMID: 20082247 BACKGROUND

• 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.

  PMID: 21824591 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04