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

NCT07712354 | Recruiting

• 1 other identifier: 602/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Spondylosis; Neck Pain; Cervical Spondylotic Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Change in neck pain intensity measured by the Visual Analog Scale (VAS)

  Neck pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). Participants indicate their pain intensity by marking a point on a horizontal line anchored by "no pain" at 0 mm and "worst imaginable pain" at 100 mm. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant's mark, yielding a possible score ranging from 0 to 100 mm. Higher scores indicate greater pain intensity and therefore a worse outcome. Changes from baseline in the VAS score at Day 7 and Day 14 will be compared between the two treatment groups.

  Baseline (N0), Day 7 (N7), and Day 14 (N14)

Secondary Outcomes (3)

• Change in functional disability measured by the Neck Disability Index (NDI)

  Baseline (N0), Day 7 (N7), and Day 14 (N14)

• Change in cervical range of motion (ROM)

  Baseline (N0), Day 7 (N7), and Day 14 (N14)

• Treatment-related adverse events

  From the first treatment session until Day 14

Study Arms (2)

High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) + PEMF

EXPERIMENTAL

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); Device: Pulsed Electromagnetic Field Therapy

Conventional High-Frequency Electroacupuncture (Meridian Points) + PEMF

ACTIVE COMPARATOR

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; Procedure: Conventional High-Frequency Electroacupuncture

Interventions

Pulsed Electromagnetic Field Therapy DEVICE

Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.

Conventional High-Frequency Electroacupuncture (Meridian Points) + PEMF; High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) + PEMF

Conventional High-Frequency Electroacupuncture PROCEDURE

High-frequency electroacupuncture (100 Hz) is applied to conventional meridian acupuncture points on the affected side according to the standardized treatment protocol.

Conventional High-Frequency Electroacupuncture (Meridian Points) + PEMF

High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) PROCEDURE

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.

High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) + PEMF

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (10)

• Suzuki A, Daubs MD, Hayashi T, Ruangchainikom M, Xiong C, Phan K, Scott TP, Wang JC. Patterns of Cervical Disc Degeneration: Analysis of Magnetic Resonance Imaging of Over 1000 Symptomatic Subjects. Global Spine J. 2018 May;8(3):254-259. doi: 10.1177/2192568217719436. Epub 2017 Aug 17.

  PMID: 29796373 BACKGROUND

• Ha Hoang Kiem. Degenerative Joint Diseases: Diagnosis, Treatment and Prevention. Sports and Tourism Publishing House. 2018.

  BACKGROUND

• Nguyen Thi Uyen Thi, Phan Quan Chi Hieu. Comparison of the analgesic effect between cervical Huatuo Jiaji electroacupuncture and conventional electroacupuncture in patients with cervical spondylotic radiculopathy caused by cervical spondylosis. Master's Thesis. University of Medicine and Pharmacy at Ho Chi Minh City. 2014.

  BACKGROUND

• Takagi I, Eliyas JK, Stadlan N. Cervical spondylosis: an update on pathophysiology, clinical manifestation, and management strategies. Dis Mon. 2011 Oct;57(10):583-91. doi: 10.1016/j.disamonth.2011.08.024. No abstract available.

  PMID: 22036114 BACKGROUND

• ICH Harmonised Guideline E6(R3). Guideline for Good Clinical Practice. International Council for Harmonisation. 2025.

  BACKGROUND

• Li W, Qu Y, Chen S, Zou X, Xia C, Ding D. Research Progress on Acupuncture Treatment for Cervical Spondylotic Radiculopathy. Zhong Yi Xue. 2024;13(10):2672-2677.

  BACKGROUND

• Guo JK, Cheng K, Zhu XC, Gong LD, Wu JT, Li JY. Clinical Observation on the Electro-acupuncture at Cervical Jiaji Point in the Treatment of Acute Cervical Spondylotic Radiculopathy. Journal of Guangzhou University of Traditional Chinese Medicine. 2023;41(2):373-378. doi:10.13359/j.cnki.gzxbtcm.2024.02.017.

  BACKGROUND

• Lin JG, Chen WL. Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med. 2008;36(4):635-45. doi: 10.1142/S0192415X08006107.

  PMID: 18711761 BACKGROUND

• Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.

  PMID: 21168100 BACKGROUND

• Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.

  PMID: 16049211 BACKGROUND

MeSH Terms

Conditions

Spondylosis; Neck Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is single-blind. Outcome assessors are independent physicians who are not involved in participant recruitment, treatment administration, or randomization and remain blinded to treatment allocation throughout the study. Treatment allocation is coded as Group A and Group B during data entry and statistical analysis to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either high-frequency electroacupuncture at cervical Huatuo Jiaji (EX-B2) points combined with pulsed electromagnetic field (PEMF) therapy or conventional high-frequency electroacupuncture combined with the same PEMF therapy. Participants will remain in their assigned treatment group throughout the study.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)