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New treatment option for Whiplash Associated Disorder (WAD)
Official title Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
ClinicalTrials.gov ID: NCT07055373
What this study is testing
- What it's testing
- 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 post-traumatic stress.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Symptom duration ≥3 months and \<10 years; and
- Classifiable as WAD grade I (neck pain without physical impairments) or II (neck pain \& impairment such as movement loss and/or tenderness) or III...
- Average pain intensity (over one week) ≥ 4/10;
- Neck Disability Index score \> 28% (14/50).
You likely can't join if
- WAD IV injury (no neurological deficit, fracture, or dislocation);
- Concussion symptoms;
- Patients who have undergone cervical vagotomy;
- Patients diagnosed with severe bradycardia;
- Patients with a permanent implanted metallic or electronic device or jewellery at close proximity to the ear tragus;
- Patients with any active implanted device (including electronic and/or medical devices) e.g. cochlear implant, cerebral shunts, invasive vagus nerve...
See the full eligibility criteria
- Symptom duration ≥3 months and \<10 years; and
- Classifiable as WAD grade I (neck pain without physical impairments) or II (neck pain \& impairment such as movement loss and/or tenderness) or III (neck pain \& neurological deficit evident on physical exam);
- Average pain intensity (over one week) ≥ 4/10;
- Neck Disability Index score \> 28% (14/50).
- WAD IV injury (no neurological deficit, fracture, or dislocation);
- Concussion symptoms;
- Patients who have undergone cervical vagotomy;
- Patients diagnosed with severe bradycardia;
- Patients with a permanent implanted metallic or electronic device or jewellery at close proximity to the ear tragus;
- 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...
- 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
- Using medications associated with ANS function such as Beta Blockers;
- 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...
- History of any mental health conditions prior to the MVC, such as bipolar disorder, schizophrenia, anxiety, PTSD or severe depression;
- People who are unable to complete the questionnaires.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.