The Safety and Feasibility of Transauricular Vagus Nerve Stimulation Therapy in Chronic Whiplash-Associated Disorders: A Randomized Pilot Trial.
Summary
The objective of this study is to evaluate the safety and feasability of transauricular vagus nerve stimulation for patients with chronic whiplash associated disorder using a take-home device, a variety of physical measurements, and questionnaires.
Approximately 50% of people with chronic whiplash-associated disorders (WAD) continue to report the presence of symptoms 12 months post-injury. These symptoms include high levels of pain and disability as well as psychological symptoms such as anxiety. The nervous system may also be affected, specifically the autonomic nervous system which is responsible for regulating heart rate and blood pressure.
An important part of the autonomic system is the vagus nerve, which helps regulate pain and stress responses. Treatment of this nerve via transauricular vagal nerve stimulation (taVNS) has been shown to improve health outcomes in many pain conditions such as chronic low back pain and postural tachycardia syndrome. TaVNS works by sending mild electrical pulses through the ear.
This project aims to explore whether or not taVNS can help people with chronic whiplash feel better. Our first goal is to evaluate the safety and feasibility of this type of study. We are interested in learning how many people with chronic WAD participate in the study and how many complete the full treatment, as well as ensuring that the treatment does not cause any serious side effects. Our additional goal is to evaluate the effects of taVNS on neck pain intensity and associated disability, pain sensitivity, heart rate variability, blood pressure, quality of life, anxiety, and depression as measured be questionnaires and physical assessments, as compared to those assigned to the sham treatment.
Eligibility
Eligible ages: 18 to 65
Inclusion criteria:
Eligibility requirements:
1. 18-65 years old
2.Whiplash symptom duration ≥3 months and <10 years; and
3. Average pain intensity ≥ 4/10;
4. Ability to complete questionnaires.
Exclusion criteria:
Exclusion Criteria
1. Neurological deficit,
2. Concussion symptoms;
3.Patients who have undergone cervical vagotomy;
4. Patients diagnosed with severe bradycardia;
5. Patients with a permanent implanted metallic or electronic device or jewellery at close proximity to the ear tragus;
6. Patients with any active implanted device (including electronic and/or medical devices) e.g. cochlear implant, cerebral shunts, invasive vagus nerve stimulators, or non-active but potentially interacting with the nervous system (e.g., metal implants);
7. Open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or cancerous lesions in the area of stimulation
8. Using medications associated such as Beta Blockers
9. Adverse general health factors such as presence of a neurological disorder (e.g., multiple sclerosis), inflammatory condition (e.g., rheumatoid arthritis), cardiovascular disorder (known severe coronary disease or recent myocardial infarction (within 5 years));
metabolic disorder (e.g., diabetes), visual deficit or disease process (e.g. cataracts, double or blurred vision), known or suspected serious spinal pathology (e.g. metastatic disease of the spine), pregnancy, or previous spinal surgery or recurrent treatment for spinal disorders;
10. History of any mental health conditions prior to the injury such as bipolar disorder, schizophrenia, anxiety, PTSD or severe depression.
11. Inability to complete questionnaires.
Participate
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Additional information
Contact information
Jennifer Laxshimalla - jennifer.laxshimalla@vivocura.ca
Principal investigator:
Ashley Smith
Clinical trial:
Yes
REB-ID:
REB25-0529