Effect of a Mobile Health App on Pain and Quality of Life in Patients With Neuropathic Pain in Multiple Sclerosis

This randomized controlled trial aims to evaluate the efficacy of a self-management-based mobile health application designed for individuals with Multiple Sclerosis (MS) who experience neuropathic pain. Neuropathic pain, affecting up to 58% of MS patients, is associated with neuroinflammation, central sensitization, and oxidative stress, often exacerbated by lifestyle factors such as poor diet, inactivity, poor sleep hygiene, stress, and smoking.

The proposed mobile application is built upon Bandura's Social Cognitive Theory and includes five core modules: self-monitoring, health education, goal-setting, skill-building, and professional support access. The app supports behavior change and provides targeted education on anti-inflammatory nutrition, physical activity, sleep hygiene, stress management, and smoking cessation, aiming to reduce neuropathic pain intensity and improve quality of life.

The app is developed using Flutter/Dart and includes interactive features such as pain diaries, daily goals, reminders, and feedback mechanisms. Educational materials are prepared with input from an interdisciplinary expert panel and validated using DISCERN and HEMDA tools.

The intervention phase will last eight weeks. Patients will be randomized into either the intervention group (app users) or the control group (usual care). Primary outcomes include reduction in pain intensity (VAS) and improvement in quality of life (MSQOL-54). Secondary measures include changes in depression (BDI), insomnia (ISI), fatigue (FSS), and self-management (MSSM).

This project addresses an unmet need for digital, non-pharmacological, evidence-based strategies to support MS patients with neuropathic pain and aims to offer a scalable and accessible solution for long-term self-management.

Inclusion criteria

• Being 18 years of age or older,
• Having a definitive diagnosis of MS according to the McDonald 2017 criteria,
• Owning a smartphone with an Android operating system,
• Having an Expanded Disability Status Scale (EDSS) score ≤ 5*,
• Being able to communicate in Turkish,
• Being literate,
• No neurological symptoms that could impair smartphone use (e.g., tremor),
• Pain Detect Pain Questionnaire score of 19 or higher,
• Neuropathic Pain Questionnaire score of 4 or higher,
• Beck Depression Scale score below 17, *EDSS scores determined by a physician's evaluation will be considered.

Exclusion criteria

• Having undergone surgical interventions on the musculoskeletal system (for at least six months),
• Having a known neurological disorder (epilepsy, dementia)*,
• Having vision or hearing problems that could affect test performance*,
• Chronic pain not attributable to neuropathic causes (cancer, carpal tunnel syndrome, postherpetic neuralgia)*,
• Peripheral vascular complications due to diabetes or other etiologies*,
• Participation in supervised exercise, home exercise, group exercise, etc., as part of physical therapy*,
• Participation in psychological therapies (cognitive and/or behavioral therapy, biofeedback), *
• Participation in mind-body practices (yoga, tai chi, etc.),*
• Participation in acupuncture, *
• Receiving invasive treatments (e.g., injections, nerve blocks, spinal cord stimulators, parenteral medications, etc.) *, * Patient self-report and medical records will be used as the basis for inclusion; patients with observed vision or hearing impairments during testing will be excluded from the study.