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

ConditionPain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jin's Three-Needle Acupuncture therapy

    Device

    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.

  • Electroacupuncture

    Device

    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 Exercises

    Behavioral

    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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Electroacupuncture + Active Movement ExercisesActive comparator 2 interventions
Group B: Jin's Three-Needle Technique + Electroacupuncture + Active Movement ExercisesExperimental treatment 3 interventions

Trial outcomes

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)).

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

Secondary outcomes

1

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)

Other outcomes

1

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

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.

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

Locations

This trial has no locations.

Sponsors and contacts

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