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NCT Number: NCT07151404

Efficacy of Acupuncture at Lieque (LU7) for Neck Pain in Cervical Spondylosis

Cervical spondylosis is a common degenerative disorder of the cervical spine that often leads to chronic neck pain, stiffness, and reduced daily functioning. Pain management in these patients remains challenging, and acupuncture is widely used as a non-pharmacological treatment option. However, the additional benefit of stimulating the Lieque (LU7) acupoint, based on the Six Command Points theory, has not been fully established.

This randomized controlled trial will evaluate whether acupuncture at Lieque (LU7), combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and cervical-shoulder points, provides greater pain relief compared to electroacupuncture at Jiaji (Ex-B2, C4-C7) and cervical-shoulder points alone.

A total of 130 participants with cervical spondylosis will be randomly assigned to two groups. Treatments will be delivered over 20 days. The primary outcome is the change in neck pain intensity, measured by a 0-100 mm Visual Analog Scale (VAS), from baseline to the end of treatment.

The findings will provide clinical evidence on the effectiveness of acupuncture at Lieque (LU7) for reducing neck pain and improving patient outcomes in cervical spondylosis.

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Key information

Conditions

Cervical Spondylosis Bone Diseases Musculoskeletal Diseases Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thu Duc City Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location contact

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

[email protected]

+84-918-949-394

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

[email protected]

+84-918-949-394

Ngoc Doan Thuy Nguyen, MD, MSc

PRINCIPAL_INVESTIGATOR

Van Dinh Le, MD

SUB_INVESTIGATOR

Xuan Sy Truong, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 years or older
  • Diagnosis of cervical spondylosis based on clinical evaluation and imaging.
  • Presence of cervical spine syndrome, including:
  • Neck and shoulder pain.
  • Limited range of motion in the cervical spine.
  • Local tenderness over the cervical spine or paraspinal region corresponding to nerve roots.
  • Radiographic evidence of cervical spondylosis on standard X-ray (frontal, lateral, or oblique views), showing one or more of the following:
  • Subchondral sclerosis.
  • Narrowing of the intervertebral disc space.
  • Osteophyte formation (bone spurs, bridging osteophytes).
  • Patients receiving treatment at Thu Duc City Hospital

Exclusion criteria

  • Patients who do not agree to participate in the study.
  • Acute torticollis, cervical disc herniation, spinal deformity, cervical spine trauma, or spinal tumors.
  • Neck and shoulder pain not caused by cervical spondylosis.
  • History of systemic diseases such as rheumatoid arthritis, severe cardiovascular disease, systemic infection, malignancy, or immunodeficiency disorders.
  • History of neurological or psychiatric conditions that impair communication or compliance, including speech disorders, impaired consciousness, psychosis, or dementia.
  • Contraindications to electroacupuncture.
  • Non-compliance with study treatment protocol.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past 10 days or local corticosteroid injection within the past 3 months.

Treatment and study plan

Acupuncture at LU7 (Lieque) + Electroacupuncture

Procedure

Participants will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints including Fengchi (GB20), Jianjing (GB21), Tianzhu (BL10), and Dazhu (BL11). Sterile disposable filiform needles (0.3 × 25 mm) will be inserted at LU7 using standard manual acupuncture technique. Electroacupuncture will be delivered with continuous wave stimulation at 60 Hz for 30 minutes per session. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.

Other names: Filiform Needle Acupuncture at Lieque (LU7), Filiform Needle Acupuncture at LU7, Filiform Needle Acupuncture

Electroacupuncture Only

Procedure

Participants will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints including Fengchi (GB20), Jianjing (GB21), Tianzhu (BL10), and Dazhu (BL11), without acupuncture at Lieque (LU7). Electroacupuncture will be delivered with continuous wave stimulation at 60 Hz for 30 minutes per session. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.

Other names: Electroacupuncture, Electroacupuncture Control, EA at Jiaji and Neck-Shoulder Acupoints, EA, Electroacupuncture at Jiaji and Neck-Shoulder Acupoints

Primary outcomes

  1. Change in Neck Pain Intensity (VAS Score)

    Time frame: Baseline (D0), Day 10 (D10), and Day 20 (D20).

    Pain intensity in the neck region will be assessed using a 100-mm Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain.

Secondary outcomes

  1. Change in Neck Pain Questionnaire (NPQ) Score

    Time frame: Baseline (D0), Day 10 (D10), and Day 20 (D20).

    The NPQ (8-item version) will be used to assess disability related to neck pain. It covers 8 domains: pain intensity, pain and sleep, nocturnal paresthesia, duration of symptoms, carrying objects, reading/TV, work/housework, and social activities. Each domain is scored 0-4; total score ranges from 0 (no disability) to 32 (severe disability). Higher scores indicate greater disability.

  2. Change in Cervical Range of Motion (ROM)

    Time frame: Baseline (D0), Day 10 (D10), and Day 20 (D20).

    Cervical spine ROM (flexion, extension, right/left lateral flexion, right/left rotation) will be measured in degrees using a goniometer (or inclinometer). Higher values indicate greater mobility.

Other outcomes

  1. Adverse Events Related to Acupuncture/Electroacupuncture

    Time frame: Throughout the 20 treatment sessions (approximately 4 weeks).

    All adverse events will be systematically recorded, including but not limited to: nausea, fatigue, dizziness, heavy numbness of the limbs, and other unexpected events. Each event will be assessed for severity (mild, moderate, severe) and its possible relationship to the intervention.

  2. Distribution of Traditional Chinese Medicine (TCM) Syndrome Types

    Time frame: At baseline (D0), prior to intervention.

    Participants will be classified into Traditional Chinese Medicine (TCM) syndromes according to TCM diagnostic criteria:

    Wind-Cold-Damp Bi Syndrome (WCDBS) Wind-Damp-Heat Bi Syndrome (WDHBS) Qi Stagnation and Blood Stasis (QSBS) Liver and Kidney Yin Deficiency (LKYD) The frequency and proportion of each syndrome type will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

[email protected]

+84-918-949-394

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

[email protected]

+84-918-949-394

Sponsors and collaborators

Lead sponsor

Nguyen Ngoc Doan Thuy

Other

Registry information

Official study title

Efficacy of Acupuncture at Lieque (LU7) Based on Six Command Points Theory, Combined With Electroacupuncture at Jiaji (Ex-B2, C4-C7) and Cervical-Shoulder Points in Cervical Spondylosis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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