Overview
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.
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.
Eligibility
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.
