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NCT06982742Completed

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

Development of a Mobile Health Application for Patients With Neuropathic Pain in Multiple Sclerosis and the Effect of the Application on Pain Intensity and Quality of Life

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
56 (actual)
First submitted
13 May 2025
Start date
20 Aug 2025
Primary completion date
30 Oct 2025
Lead sponsor
Meryem Kocaslan Toran
NCT number
NCT06982742

What you commit to

  • Study type: Interventional
  • Participants enrolled: 56
  • From 20 Aug 2025 to the primary completion date, 30 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Aged 18 years or older
  • Definite diagnosis of multiple sclerosis according to the 2017 McDonald criteria
  • Expanded Disability Status Scale score ≤5.5, assessed by a neurologist
  • Neuropathic pain confirmed by a Douleur Neuropathique 4 score ≥4 and a painDETECT score ≥19
  • Pain severity ≥1 on a Visual Analogue Scale
  • Beck Depression Inventory score \<17
  • Ownership of an Android smartphone
  • Literate in Turkish
  • No neurological symptoms impeding smartphone use
  • Willing to provide written informed consent Exclusion criteria
    • 1 Musculoskeletal surgery within the preceding six months 2 Multiple sclerosis relapse within the preceding month 3 Intravenous or oral corticosteroid treatment within the preceding month 4 Another neurological disorder 5 Visual or auditory impairment affecting completion of the assessments 6 Chronic pain of non-neuropathic origin 7 Peripheral vascular complications due to diabetes or other aetiologies 8 Concurrent participation in a supervised exercise programme, psychological therapy, mind-body practice, acupuncture or invasive pain intervention

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uskudar University, Faculty of Health Sciences
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.