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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: High-Frequency Electroacupuncture at Cervical Huatuo Jiaji (EX-B2) (Procedure)
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).
干预措施: Pulsed Electromagnetic Field Therapy (Device)
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).
干预措施: Pulsed Electromagnetic Field Therapy (Device)
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).
干预措施: Conventional High-Frequency Electroacupuncture (Procedure)
结局指标
主要结局
Change in pain intensity measured by the Visual Analog Scale (VAS)
时间窗: 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.
Change in neck pain intensity measured by the Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Change in cervical range of motion (ROM)(Baseline (N0), Day 7 (N7), and Day 14 (N14))
- Change in Neck Disability Index (NDI)(Baseline (N0), Day 7 (N7), and Day 14 (N14))
- Treatment-related adverse events(From the first treatment session until Day 14)
- Change in functional disability measured by the Neck Disability Index (NDI)(Baseline (N0), Day 7 (N7), and Day 14 (N14))
研究者
Nguyen Dinh Kien
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City