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

N/ANot Yet RecruitingNCT07559279

University of Medicine and Pharmacy at Ho Chi Minh City104 enrolled

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.

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).

Study Type

Interventions

Jin's Three-Needle Acupuncture therapyDEVICE

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.

ElectroacupunctureDEVICE

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.

Active Movement ExercisesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)).

Time frame: Assessments will be conducted before the intervention (D0), 1 week of intervention (D7), and 2 weeks of intervention (D14).

Secondary Outcomes

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

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%).

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