Compare the Effectiveness of Non-invasive Vagus Nerve Stimulation (nVNS) and Non-invasive Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Life (QOL) in Patients of Migraine: a Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Superior University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Visual analogue scale (VAS)
Study Overview
Brief Summary
Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Migraine has an approximate prevalence of 14.7%, making it the third most common disease in the world. This study aims to compare the effectiveness of non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in managing pain and improving quality of life (QOL) in patients with migraine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •People will be eligible for participation of 18-75 years of age.
- •Participants are included with previous diagnosis of migraine with aura according to ICHD-3 beta criteria.
- •Patients who had 15 headache days per month over the last 6 months will be included in this study.
Exclusion Criteria
- •Participants with a history of secondary headaches,
- •aneurysms, brain tumors, significant head trauma
- •substance abuse, cardiovascular or cerebrovascular disease
- •uncontrolled hypertension, psychiatric disorders,
- •pregnancy, steroid use, botulinum toxin injections in the past 6 months, or certain other medical conditions were excluded.
- •individuals with excessive use of pain medications, recent preventive treatments, or previous surgeries and procedures related to migraines will not be eligible.
Arms & Interventions
non-invasive vagus nerve stimulation (nVNS)
Intervention: non-invasive vagus nerve stimulation (nVNS) (Combination Product)
non-invasive transcutaneous electrical nerve stimulation (TENS)
Intervention: non-invasive transcutaneous electrical nerve stimulation (TENS) (Combination Product)
Outcomes
Primary Outcomes
Visual analogue scale (VAS)
Time Frame: 12 Months
The Visual Analogue Scale (VAS) is a simple tool used to measure the intensity of pain or symptoms. It typically uses a 10 cm (100 mm) horizontal line, where: 0 = No pain 10 = Worst imaginable pain
HIT-6 (Headache impact test)
Time Frame: 12 Months
The HIT-6 (Headache Impact Test) is a tool used to assess the impact of headaches, particularly migraines, on a person's daily life. It evaluates how headaches/pain affect daily functioning, work, social activities, and emotional well-being. The HIT-6 consists of 6 items. Each item is rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Very often, and 5 = Always). The individual responses are summed to obtain a total score that ranges from 36 to 78, with higher scores indicating greater headache impact and lower scores indicating less impact (below 50 suggests low impact, between 50 and 55 suggests moderate impact, and above 55 suggests severe impact).
MIDAS (Migraine Disability Assessment)
Time Frame: 12 Months
The MIDAS (Migraine Disability Assessment) scale is a tool used to assess how migraines impact a person's daily life over the past three months. It includes five questions that ask about the number of days missed or affected in work, school, household tasks, and social activities due to migraines. The total number of days gives a MIDAS score, which is then categorized into four grades: Grade I (0-5) for little or no disability, Grade II (6-10) for mild, Grade III (11-20) for moderate, and Grade IV (21+) for severe disability. This helps clinicians evaluate the level of functional impairment caused by migraines
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Naveed Babur
Principal Investigator
Superior University