Effect of a Mobile Health App on Pain and Quality of Life in Patients With Neuropathic Pain in Multiple Sclerosis
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 12 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Mobile Health App for Neuropathic Pain Management in MS
What it measured
Main measures
Change in Neuropathic Pain Severity Measured by the Visual Analogue Scale
Baseline and 8 weeks after intervention start
PainChange in Physical Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Baseline and 8 weeks after intervention start
Quality of life (reported by participants)Change in Mental Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Baseline and 8 weeks after intervention start
Quality of life (reported by participants)
Other measures (4)
Change in Fatigue Measured by the Fatigue Severity Scale
Baseline and 8 weeks after intervention start
FatigueChange in Insomnia Severity Measured by the Insomnia Severity Index
Baseline and 8 weeks after intervention start
Mood and sleepChange in Health-Promoting Lifestyle Behaviours Measured by the Health-Promoting Lifestyle Profile II
Baseline and 8 weeks after intervention start
Change in Self-Management Measured by the Multiple Sclerosis Self-Management Scale
Baseline and 8 weeks after intervention start
Who could take part
MS (type not specified) · 18 and over
Inclusion criteria 1. Aged 18 years or older 2. Definite diagnosis of multiple sclerosis according to the 2017 McDonald criteria 3. Expanded Disability Status Scale score ≤5.5, assessed by a neurologist 4. Neuropathic pain confirmed by a Douleur Neuropathique 4 score ≥4 and a painDETECT score ≥19 5. Pain severity ≥1 on a Visual Analogue Scale 6. Beck Depression Inventory score \<17 7. Ownership of an Android smartphone 8. Literate in Turkish 9. No neurological symptoms impeding smartphone use 10. 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
- Status changed from Not yet recruiting to Completed
- Enrollment changed from 52 to 56
- Primary completion date changed from 2025-10-01 to 2025-10-30
- Completion date changed from 2025-12-15 to 2025-12-30
- Result signal changed from ongoing to completed_recent_or_undated
Started
Aug 2025
Main results due
Oct 2025
Finished
Dec 2025
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