Cervical Radiculopathy, Cervical Spondylosis, Radicular Pain
Conditions
Keywords
taVNS, transcutaneous auricular vagus nerve stimulation, cervical epidural injection; cervical radiculopathy, pain, arm pain, pain management, neuromodulation
Brief summary
This is a prospective, randomized, double-blinded, sham-controlled trial conducted to investigate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) combined with cervical epidural injection in the treatment of cervical radiculopathy. A total of 80 subjects will be enrolled and randomly assigned (1:1) to either the experimental group or the control group. The primary outcome measure is the proportion of subjects with a ≥50% reduction in the Numerical Rating Scale (NRS) pain score at discharge. Secondary outcomes include pain intensity, pain interference, psychological status, sleep quality, physical disability, and autonomic function measurements. Adverse events will be monitored throughout the study.
Detailed description
Cervical radiculopathy is a common condition associated with significant neck and arm pain, often resulting from cervical spondylosis. Current management strategies include epidural injections and pharmacotherapy; however, adjunctive neuromodulation therapies are being explored. This study aims to evaluate the additive effect of taVNS, a non-invasive neuromodulation technique, when combined with cervical epidural injection. Study Design: Eighty patients diagnosed with cervical radiculopathy scheduled for cervical epidural injection will be recruited. Participants will be randomly allocated in a 1:1 ratio to two groups: * Experimental Group: Subjects will receive 3 consecutive days of preoperative taVNS stimulation (1-2 hours/day, 30Hz, 200μs, up to 50mA) followed by a standard cervical epidural injection of corticosteroid and local anesthetic. * Control Group: Subjects will receive a sham taVNS stimulation (identical device with no output) for the same duration and frequency, followed by the same standard cervical epidural injection. Outcomes: The primary endpoint is the proportion of subjects achieving a ≥50% reduction in NRS pain score at discharge. Secondary endpoints include changes in Brief Pain Inventory (BPI) scores, Hospital Anxiety and Depression Scale (HADS) scores, Insomnia Severity Index (ISI) scores, Neck Disability Index (NDI), and heart rate variability (HRV) measurements at predefined time points (preoperatively, 24 hours postoperatively, and at discharge). Safety outcomes include the incidence of adverse events and changes in cardiac function. This study will provide high-level evidence on the efficacy and safety of combining taVNS with cervical epidural injection for the treatment of acute cervical radiculopathy.
Interventions
Preoperative non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) administered for 3 consecutive days, 1-2 hours daily. Electrode placed on the left cymba conchae. Parameters: 30Hz frequency, 200μs pulse width, current titrated to patient tolerance (max 50mA).
PROCEDURECervical Epidural Injection
Standard cervical epidural injection of corticosteroid and local anesthetic, identical to the experimental group, administered per clinical routine.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study employs a double-blind design. Participants and outcome assessors are blinded to group assignment throughout the study. The intervention is administered by a dedicated research team member who is not involved in outcome assessment, ensuring blinding integrity.
Intervention model description
This is a parallel-group, randomized, double-blind, sham-controlled trial. Eighty eligible participants will be randomly assigned in a 1:1 ratio to either the transcutaneous auricular vagus nerve stimulation (taVNS) combined with cervical epidural injection group or the sham taVNS combined with cervical epidural injection group. Both participants and outcome assessors will be blinded to group allocation throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 85 years old. 2. Body Mass Index (BMI) between 18 and 35 kg/m². 3. American Society of Anesthesiologists (ASA) physical status I to III. 4. Diagnosed with cervical radiculopathy, scheduled for selective cervical epidural injection. 5. Estimated procedure duration ≤ 1 hour. 6. Able to understand and provide written informed consent.
Exclusion criteria
1. Arrhythmia requiring treatment, severe bradycardia, or postural orthostatic tachycardia syndrome. 2. Neuromuscular disorders or auricular dermatitis. 3. Cervical fracture, tumor, tuberculosis, or active infection confirmed by imaging. 4. Contraindications to vagus nerve stimulation: carotid sinus hypersensitivity, bilateral carotid artery stenosis. 5. Severe psychiatric disorder or history of substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving ≥50% Reduction in NRS Pain Score | Post-procedure Day 1 | The proportion of participants achieving a ≥50% reduction in Numerical Rating Scale (NRS) pain score from baseline to the post-procedure day 1 assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative, 24 hours postoperatively, and post-procedure day 1 | Preoperative, 24 hours postoperatively, and post-procedure day 1 | Changes in Brief Pain Inventory (BPI) scores, including worst, least, average, and current pain intensity, as well as pain interference with daily activities, measured from preoperative baseline to 24 hours postoperatively and post-procedure day 1. |
| Hospital Anxiety and Depression Scale (HADS) Score Changes | Preoperative and post-procedure day 1 | Changes in Hospital Anxiety and Depression Scale (HADS) scores, including anxiety and depression subscales, measured from the preoperative baseline to post-procedure day 1 to evaluate psychological status. |
| Insomnia Severity Index (ISI) Score Changes | Preoperative and post-procedure day 1 | Changes in Insomnia Severity Index (ISI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in sleep quality. |
| Neck Disability Index (NDI) Score Changes | Preoperative and post-procedure day 1 | Changes in Neck Disability Index (NDI) scores, measured from the preoperative baseline to post-procedure day 1, to evaluate improvements in neck function and daily activity ability. |
Countries
China
Contacts
CONTACTLina Yu, MD
PRINCIPAL_INVESTIGATORLina Yu
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed