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

NCT06982742 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-25

No results posted yet for this study

Summary

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system, leading to inflammation, neurodegeneration, and a range of physical and invisible symptoms. Among these, neuropathic pain significantly impairs quality of life but is often overlooked. Neuropathic pain in MS is associated with increased central sensitivity, neuroinflammation, and lifestyle factors such as unhealthy diet, physical inactivity, poor sleep, stress, and smoking. While pharmacological treatments are commonly used, they often provide limited long-term relief and may carry risks such as dependence and side effects.

Growing evidence highlights the importance of non-pharmacological, self-management interventions that promote lifestyle changes. Digital health technologies, particularly mobile health (mHealth) applications, have emerged as accessible tools to support self-management, allowing individuals to take an active role in managing their symptoms and improving their well-being. However, existing mHealth applications often lack scientifically validated content, do not specifically address neuropathic pain, and have limited user-centered design features.

This study aims to develop a self-management-based mHealth application tailored for patients with MS experiencing neuropathic pain. Grounded in Bandura's Social Cognitive Theory, the application will provide educational content, symptom tracking, goal-setting tools, and behavior change strategies covering topics such as nutrition, physical activity, sleep hygiene, stress management, and smoking cessation. The application seeks to improve self-efficacy, reduce pain intensity, and enhance quality of life.

The study will be conducted as a randomized controlled trial. Participants will be randomly assigned to an intervention group (using the mHealth application for eight weeks) or a control group (receiving standard care). Primary outcomes include changes in pain intensity and quality of life. The study hypothesizes that using the mobile application will reduce pain intensity and improve quality of life compared to standard care.

Additionally, the study sets measurable success criteria for the development and evaluation of the application, including expert and user evaluations of content quality, usability, and user satisfaction. The findings aim to contribute to the literature on integrative pain management and demonstrate the

Conditions

Interventions

OTHER

Mobile Health App for Neuropathic Pain Management in MS

This intervention is a self-management mobile health application specifically designed for patients with Multiple Sclerosis who experience neuropathic pain. Unlike general symptom tracking apps, this application provides structured educational content on anti-inflammatory nutrition, physical activity, sleep hygiene, stress management, and smoking cessation. It includes goal-setting features, personalized reminders, symptom tracking tools, and feedback mechanisms to promote behavior change and self-efficacy. The intervention is designed based on Social Cognitive Theory, aiming to empower patients to actively manage their pain and improve their quality of life. T

Sponsors & Collaborators

  • Uskudar University

    collaborator OTHER
  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER
  • Meryem Kocaslan Toran

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-01
Completion
2025-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982742 on ClinicalTrials.gov