Compare the Effectiveness of nVNS and TENS on Pain and Quality of Life in Patients of Migraine

Not Applicable

Active, not recruiting

• Conditions: Migraine

• Registration Number: NCT07055776
• Lead Sponsor: Superior University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-17
• Status Verified: 2025-06
• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-06-28
• Last Update Submitted: 2025-06-28
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-09-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	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)	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)	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

Trial Locations

Locations (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University; 🇵🇰 Lahore, Punjab, Pakistan