High-Frequency Electroacupuncture at Cervical Huatuo Jiaji Points Combined With Electromagnetic Field Therapy for Cervical Spondylotic Radiculopathy

July 14, 2026 updated by: Nguyen Dinh Kien, University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy of High-Frequency Electroacupuncture at Cervical Huatuo Jiaji Points Combined With Electromagnetic Field Therapy in the Treatment of Cervical Spondylotic Radiculopathy Due to Cervical Spondylosis: A Randomized Controlled Trial

Cervical spondylotic radiculopathy (CSR) is one of the most common manifestations of cervical spondylosis and is characterized by neck pain radiating to the upper extremities, sensory disturbances, restricted cervical range of motion, and functional disability. Conservative treatment is recommended as the first-line management for most patients, and electroacupuncture is widely used in Traditional Medicine to relieve pain and improve function.

Cervical Huatuo Jiaji (EX-B2) acupuncture points are anatomically located adjacent to the cervical spinal nerve roots and may provide more targeted therapeutic effects than conventional meridian acupuncture points. Pulsed electromagnetic field (PEMF) therapy has also been used as an adjunctive physical modality to reduce pain and facilitate functional recovery.

This randomized controlled trial aims to evaluate whether high-frequency electroacupuncture at cervical Huatuo Jiaji (EX-B2) points combined with PEMF therapy provides greater improvement in pain intensity, cervical function, and safety outcomes than conventional high-frequency electroacupuncture combined with PEMF therapy in patients with cervical spondylotic radiculopathy caused by cervical spondylosis.

The primary outcome is pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include cervical range of motion, Neck Disability Index (NDI), and treatment-related adverse events. Clinical outcomes will be assessed at baseline, after one week of treatment, and at the end of the two-week treatment period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a prospective, randomized, single-blind, parallel-group controlled trial. A total of 104 patients diagnosed with cervical spondylotic radiculopathy caused by cervical spondylosis will be recruited and randomly assigned in a 1:1 ratio into two groups using a computer-generated randomization sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.

Experimental Group: Patients will receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy.

Active Comparator Group: Patients will receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy.

Treatment Procedure:

  • A total of 104 participants will be enrolled, with 52 participants allocated to each study group.
  • Both groups will receive one treatment session daily, Monday through Friday, for two consecutive weeks (10 treatment sessions). Each electroacupuncture session will last approximately 20 minutes.
  • All interventions will be performed according to standardized treatment protocols by licensed Traditional Medicine physicians who have received protocol-specific training before study initiation.
  • No additional acupuncture interventions outside the study protocol will be permitted during the study period.

Data Collection and Evaluation:

Outcome measures will be assessed at three predefined time points:

  • N0: Baseline (before treatment)
  • N7: After one week of treatment
  • N14: End of the two-week treatment period

The primary and secondary outcomes include:

Pain intensity: Measured using the Visual Analog Scale (VAS). Cervical range of motion: Measured using a cervical goniometer. Functional disability: Measured using the Neck Disability Index (NDI). Safety: Recording treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, allergic reactions, infection, and other intervention-related adverse events throughout the study period.

To ensure objectivity, outcome assessments will be conducted by blinded physicians who are not involved in participant recruitment, treatment administration, or randomization. During data entry and statistical analysis, treatment allocation will be coded as Group A and Group B to minimize assessment bias. Statistical analyses will be performed using Generalized Estimating Equations (GEE), with statistical significance defined as a two-sided P value <0.05.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent to participate in the study.
  • Male or female patients aged 30 years or older.
  • Inpatients or outpatients diagnosed with cervical spondylotic radiculopathy caused by cervical spondylosis at Ho Chi Minh City Hospital of Traditional Medicine.
  • Clinical diagnosis of cervical spondylotic radiculopathy, including:
  • Neck pain radiating to the shoulder and/or upper extremity.
  • Sensory disturbance and/or motor deficit and/or abnormal deep tendon reflexes consistent with the affected cervical nerve root.
  • At least one positive provocative test (Spurling test, cervical percussion/compression test, cervical distraction test, or shoulder abduction relief test).
  • Pain intensity of at least 3 on the Visual Analog Scale (VAS).
  • Clinical evidence of cervical spine syndrome.
  • Cervical spine X-ray demonstrating at least one degenerative finding (osteophytes, intervertebral disc space narrowing, or subchondral sclerosis).

Exclusion Criteria:

  • Cervical radiculopathy caused by conditions other than cervical spondylosis.
  • Cervical myelopathy or other spinal cord disorders requiring surgical intervention.
  • Severe systemic illness, frailty, or medical conditions requiring intensive care, or suspected malignancy indicated by unexplained fever, unexplained weight loss, immunodeficiency, or cancer.
  • Contraindications to acupuncture, including skin infection or ulceration at the acupuncture site, allergy to acupuncture needles, severe needle phobia, or psychiatric disorders preventing cooperation.
  • Current treatment with strong analgesics (including paracetamol/codeine combinations, tramadol, or strong opioids) or other therapies that may interfere with study outcomes.
  • Implanted cardiac pacemakers or other implanted electronic medical devices (e.g., neurostimulators, implantable cardioverter-defibrillators, or insulin pumps).
  • Bleeding disorders or hematologic diseases affecting coagulation.
  • Benign or malignant tumors involving the treatment area or systemic malignancy.
  • Participation in another interventional clinical trial.
  • Inability to communicate effectively in Vietnamese.
  • Pregnant women or women with suspected pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) + PEMF
Participants receive high-frequency electroacupuncture (100 Hz) at bilateral cervical Huatuo Jiaji (EX-B2) points corresponding to the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments combined with pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions).
Procedure: High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2)
High-frequency electroacupuncture (100 Hz) is applied to bilateral cervical Huatuo Jiaji (EX-B2) acupuncture points at the C4-C5, C5-C6, C6-C7, and C7-T1 spinal segments using standardized stimulation parameters.
Device: Pulsed Electromagnetic Field Therapy
Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
Active Comparator: Conventional High-Frequency Electroacupuncture (Meridian Points) + PEMF
Participants receive high-frequency electroacupuncture (100 Hz) at conventional meridian acupuncture points on the affected side combined with the same pulsed electromagnetic field (PEMF) therapy. Treatment is administered once daily, Monday through Friday, for two consecutive weeks (10 treatment sessions).
Device: Pulsed Electromagnetic Field Therapy
Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
Procedure: Conventional High-Frequency Electroacupuncture
High-frequency electroacupuncture (100 Hz) is applied to conventional meridian acupuncture points on the affected side according to the standardized treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured by the Visual Analog Scale (VAS)
Time Frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). The primary outcome is the change in VAS score over the treatment period and the comparison of changes between the two treatment groups.
Baseline (N0), Day 7 (N7), and Day 14 (N14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cervical range of motion (ROM)
Time Frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
Cervical range of motion (flexion, extension, lateral flexion, and rotation) will be measured using a cervical goniometer. Changes from baseline will be compared between the two treatment groups.
Baseline (N0), Day 7 (N7), and Day 14 (N14)
Change in Neck Disability Index (NDI)
Time Frame: Baseline (N0), Day 7 (N7), and Day 14 (N14)
Functional disability related to neck pain will be assessed using the Neck Disability Index (NDI). Changes in NDI scores over time and between treatment groups will be evaluated.
Baseline (N0), Day 7 (N7), and Day 14 (N14)
Treatment-related adverse events
Time Frame: From the first treatment session until Day 14
Treatment-related adverse events, including bleeding, hematoma, localized pain, dizziness, needle syncope, infection, allergic reactions, and other intervention-related adverse events, will be recorded throughout the study.
From the first treatment session until Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602/ĐHYD-HĐĐĐ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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