NCT07151404

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 19, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Cervical SpondylosisNeck PainCervical SpineAcupunctureElectroacupunctureLieque PointLU7 AcupointJiaji PointsCervical-Shoulder AcupointsRandomized Controlled TrialLU7Ex-B2Ex-B2, C4-C7

Outcome Measures

Primary Outcomes (1)

  • Change in Neck Pain Intensity (VAS Score)

    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.

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

Secondary Outcomes (2)

  • Change in Neck Pain Questionnaire (NPQ) Score

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

  • Change in Cervical Range of Motion (ROM)

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

Other Outcomes (2)

  • Adverse Events Related to Acupuncture/Electroacupuncture

    Throughout the 20 treatment sessions (approximately 4 weeks).

  • Distribution of Traditional Chinese Medicine (TCM) Syndrome Types

    At baseline (D0), prior to intervention.

Study Arms (2)

Lieque (LU7) + Electroacupuncture

EXPERIMENTAL

Participants will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints. Sterile disposable filiform needles (0.3 × 25 mm) will be used. Electroacupuncture will be applied at 60 Hz continuous wave for 30 minutes per session. Treatment will be given once daily for a total of 20 sessions, excluding Sundays (approximately 4 weeks).

Procedure: Acupuncture at LU7 (Lieque) + Electroacupuncture

Electroacupuncture Only

ACTIVE COMPARATOR

Participants will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints only, without acupuncture at Lieque (LU7). Electroacupuncture will be applied at 60 Hz continuous wave for 30 minutes per session. Treatment will be given once daily for a total of 20 sessions, excluding Sundays (approximately 4 weeks).

Procedure: Electroacupuncture Only

Interventions

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.

Also known as: Filiform Needle Acupuncture at Lieque (LU7), Filiform Needle Acupuncture at LU7, Filiform Needle Acupuncture
Lieque (LU7) + Electroacupuncture

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.

Also known as: Electroacupuncture, Electroacupuncture Control, EA at Jiaji and Neck-Shoulder Acupoints, EA, Electroacupuncture at Jiaji and Neck-Shoulder Acupoints
Electroacupuncture Only

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thu Duc City Hospital

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

Location

MeSH Terms

Conditions

SpondylosisNeck Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Ngoc Doan Thuy Nguyen, MD, MSc

    University of Health Sciences, Vietnam National University Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

Ngoc Doan Thuy Nguyen, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two groups. The experimental group will receive filiform needle acupuncture at Lieque (LU7) combined with electroacupuncture at Jiaji (Ex-B2, C4-C7) and selected neck-shoulder acupoints. The control group will receive electroacupuncture at Jiaji (Ex-B2, C4-C7) and neck-shoulder acupoints only. Treatment will be performed once daily for a total of 20 sessions over approximately 4 weeks, excluding Sundays.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc, MD, Lecturer, Department of Acupuncture, School of Medicine - Vietnam National University at Ho Chi Minh City

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to concerns regarding data confidentiality and patient privacy.

Locations