High-Frequency Electroacupuncture at Cervical Huatuo Jiaji Points Combined With Electromagnetic Field Therapy for Cervical Spondylotic Radiculopathy
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Ho Chi Minh City、ベトナム
- 募集
- University of Medicine and Pharmacy at Ho Chi Minh City
-
コンタクト：
- Nguyen Dinh Kien, Dr
- 電話番号：+84919990324
- メール：ndkien.ckii.yhct24@ump.edu.vn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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.
Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
|
|
アクティブコンパレータ：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).
|
Pulsed electromagnetic field (PEMF) therapy is administered according to the standardized treatment protocol during each treatment session.
High-frequency electroacupuncture (100 Hz) is applied to conventional meridian acupuncture points on the affected side according to the standardized treatment protocol.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in neck pain intensity measured by the Visual Analog Scale (VAS)
時間枠：Baseline (N0), Day 7 (N7), and Day 14 (N14)
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cervical range of motion (ROM)
時間枠：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)
|
|
Treatment-related adverse events
時間枠：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
|
|
Change in functional disability measured by the Neck Disability Index (NDI)
時間枠：Baseline (N0), Day 7 (N7), and Day 14 (N14)
|
Functional disability related to neck pain will be assessed using the 10-item Neck Disability Index (NDI).
Each item is scored from 0 to 5, yielding a total score ranging from 0 to 50 points, where 0 indicates no disability and 50 indicates maximum disability.
Higher scores indicate greater neck-related disability.
Changes from baseline in the total NDI score at Day 7 and Day 14 will be compared between the two treatment groups.
|
Baseline (N0), Day 7 (N7), and Day 14 (N14)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- Ha Hoang Kiem. Degenerative Joint Diseases: Diagnosis, Treatment and Prevention. Sports and Tourism Publishing House. 2018.
- 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.
- ICH Harmonised Guideline E6(R3). Guideline for Good Clinical Practice. International Council for Harmonisation. 2025.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。