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

Official title

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

Overview

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.

Detailed description

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).

Interventions

• Device 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.
• Device 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.
• Behavioral 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.

Primary outcome measures

• 1. The change of the Visual Analog Scale (VAS) [Time frame: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14).]

Secondary outcome measures (1)

• The change in the Questionnaire Douleur Saint Antoine (QDSA) score [Time frame: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07559279 · 497/HDDD-DHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗