Multiple SclerosisNCT06982742
Effect of a Mobile Health App on Pain and Quality of Life in Patients With Neuropathic Pain in Multiple Sclerosis
A study testing Mobile Health App for Neuropathic Pain Management in MS in people with Multiple Sclerosis, run by Meryem Kocaslan Toran at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mobile Health App for Neuropathic Pain Management in MS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University, Faculty of Health Sciences
Istanbul
About this study
Official title: 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
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.
Read more
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
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Mobile Health App for Neuropathic Pain Management in MS
- Keywords
- multiple sclerosis, neuroparthic pain, quality opf life, mobile health aplication
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health App for Neuropathic Pain Management in MSOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Name: Mobile Health Application Group (Intervention) | Experimental | Participants will use the mobile health application for 8 weeks. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neuropathic Pain Severity Measured by the Visual Analogue Scale
Neuropathic pain severity was assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain severity. Change in VAS score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Change in Physical Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Physical health-related quality of life was assessed using the Physical Health Composite of the Multiple Sclerosis Quality of Life-54 (MSQOL-54). Scores range from 0 to 100, with higher scores indicating better physical health-related quality of life. Change in the Physical Health Composite score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Change in Mental Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Mental health-related quality of life was assessed using the Mental Health Composite of the Multiple Sclerosis Quality of Life-54 (MSQOL-54). Scores range from 0 to 100, with higher scores indicating better mental health-related quality of life. Change in the Mental Health Composite score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Secondary outcomes (4)
Change in Fatigue Measured by the Fatigue Severity Scale
Fatigue was assessed using the Fatigue Severity Scale (FSS). Total scores range from 9 to 63, with higher scores indicating greater fatigue severity. Change in FSS score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Change in Insomnia Severity Measured by the Insomnia Severity Index
Insomnia severity was assessed using the Insomnia Severity Index (ISI). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity. Change in ISI score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Change in Health-Promoting Lifestyle Behaviours Measured by the Health-Promoting Lifestyle Profile II
Health-promoting lifestyle behaviours were assessed using the Health-Promoting Lifestyle Profile II (HPLP-II). Total scores range from 52 to 208, with higher scores indicating more frequent health-promoting lifestyle behaviours. Change in HPLP-II score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Change in Self-Management Measured by the Multiple Sclerosis Self-Management Scale
Self-management was assessed using the Multiple Sclerosis Self-Management Scale (MSSM). Total scores range from 24 to 120, with higher scores indicating better self-management. Change in MSSM score from baseline to week 8 was evaluated.
Measured: Baseline and 8 weeks after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 Aug 2025
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meryem Kocaslan Toran
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University, The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Meryem Kocaslan Toran, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982742
- Sponsor's protocol ID
- UskudarU-MS-PAINAPP-2025
- Other IDs
- TUBITAK 1002- 424S249
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06982742
- Acronym / sponsor ID
- UskudarU-MS-PAINAPP-2025
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, neuroparthic pain, quality opf life, mobile health aplication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Meryem Kocaslan ToranUniversity, hospital or other
- Collaborators
- Uskudar University, The Scientific and Technological Research Council of Turkey
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Name: Mobile Health Application Group (Intervention) | Experimental | Other: Mobile Health App for Neuropathic Pain Management in MSParticipants will use the mobile health application for 8 weeks. |
| Arm 2 Name: Standard Care Group (Control) | No intervention | –Participants will receive standard care without the mobile health application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health App for Neuropathic Pain Management in MSThis 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 | Other | Arm 1 Name: Mobile Health Application Group (Intervention) |
Primary outcome
Change in Neuropathic Pain Severity Measured by the Visual Analogue Scale
Time frame: Baseline and 8 weeks after intervention start
Neuropathic pain severity was assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain severity. Change in VAS score from baseline to week 8 was evaluated.
Change in Physical Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Time frame: Baseline and 8 weeks after intervention start
Physical health-related quality of life was assessed using the Physical Health Composite of the Multiple Sclerosis Quality of Life-54 (MSQOL-54). Scores range from 0 to 100, with higher scores indicating better physical health-related quality of life. Change in the Physical Health Composite score from baseline to week 8 was evaluated.
Change in Mental Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54
Time frame: Baseline and 8 weeks after intervention start
Mental health-related quality of life was assessed using the Mental Health Composite of the Multiple Sclerosis Quality of Life-54 (MSQOL-54). Scores range from 0 to 100, with higher scores indicating better mental health-related quality of life. Change in the Mental Health Composite score from baseline to week 8 was evaluated.
4 secondary outcomes
Change in Fatigue Measured by the Fatigue Severity Scale
Time frame: Baseline and 8 weeks after intervention start
Change in Insomnia Severity Measured by the Insomnia Severity Index
Time frame: Baseline and 8 weeks after intervention start
Change in Health-Promoting Lifestyle Behaviours Measured by the Health-Promoting Lifestyle Profile II
Time frame: Baseline and 8 weeks after intervention start
Change in Self-Management Measured by the Multiple Sclerosis Self-Management Scale
Time frame: Baseline and 8 weeks after intervention start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health App for Neuropathic Pain Management in MS in people with Multiple Sclerosis, run by Meryem Kocaslan Toran at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropathic Pain Severity Measured by the Visual Analogue Scale (time frame: Baseline and 8 weeks after intervention start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.