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

NCT06982742 | Not Yet Recruiting DMC

• 2 other identifiers: UskudarU-MS-PAINAPP-2025TUBITAK 1002- 424S249
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

multiple sclerosis; neuroparthic pain; quality opf life; mobile health aplication

Outcome Measures

Primary Outcomes (1)

• Reduction in Neuropathic Pain Intensity Measured by Visual Analog Scale (VAS)

  Assessment of change in neuropathic pain intensity using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst imaginable pain), comparing baseline and 8-week follow-up scores between the intervention and control groups in a randomized controlled trial.

  Baseline and 8 weeks after intervention start

Secondary Outcomes (1)

• Improvement in Quality of Life Measured by Multiple Sclerosis Quality of Life-54 (MSQOL-54)

  Baseline and 8 weeks after intervention start

Study Arms (2)

Arm 1 Name: Mobile Health Application Group (Intervention)

EXPERIMENTAL

Participants will use the mobile health application for 8 weeks.

Other: Mobile Health App for Neuropathic Pain Management in MS

Arm 2 Name: Standard Care Group (Control)

NO INTERVENTION

Participants will receive standard care without the mobile health application.

Interventions

Mobile Health App for Neuropathic Pain Management in MS OTHER

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

Arm 1 Name: Mobile Health Application Group (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, \*

Sponsors & Collaborators

• Meryem Kocaslan Toran: lead
• Uskudar University: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Uskudar University, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Meryem Kocaslan Toran, PhD (c)

CONTACT

00905066000080; meryemkocaslan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Arm 1 Name: Mobile Health Application Group Intervention: Behavioral - Use of a Mobile Health Application Arm 2 Name: Standard Care Group Intervention: No Intervention - Standard Care

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 15, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)