ClinicalTrials.gg
CompletedNCT06982742Updated Oct 27, 2026

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

An interventional study of Mobile Health App for Neuropathic Pain Management in MS in Multiple Sclerosis, sponsored by Meryem Kocaslan Toran. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Meryem Kocaslan Toran · Not applicable, Interventional, and Supportive care

Updated Oct 27, 2026Now CompletedStart date moved+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 307 studies in Multiple Sclerosis with a site in Turkey — 59 open to participants now, 78 under way, 10 of them phase 3. Multiple Sclerosis · Turkey.

Enrollment
73rd of 204
56 · median 40
Started
2025
with 36 others
No phase
155 of 307
31 open now
Registered
230th of 307
by date

Among the 307 studies in Multiple Sclerosis with a site in Turkey, this one is the 73rd largest by enrollment of the 204 interventional ones, is one of 37 that started in 2025, is one of 155 with no phase, and was the 230th registered.

By phase

307 studies; the count open now beside each. This study's row is marked.

No phasethis study155 · 31 open
Observational103 · 27 open
Phase 340 · 1 open
Phase 26 · 0 open
Phase 43 · 0 open

By the year they started

First in 2004; this study’s year is marked. 37 started in 2025.

Size and results

Median enrollment 40 across the 204 interventional studies, 60 across the 103 observational. Of the 204 that completed or were terminated, 37 (18%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 307 studies in Multiple Sclerosis with a site in Turkey, or all of them as a file.
02

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

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.

03

Conditions studied

  • Multiple Sclerosis

Browse trials for

Keywords

  • multiple sclerosis
  • neuroparthic pain
  • quality opf life
  • mobile health aplication
04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 Exclusion criteria

1 Musculoskeletal surgery within the preceding six months 2 Multiple sclerosis relapse within the preceding month 3 Intravenous or oral 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Arm 1 Name: Mobile Health Application Group (Intervention)

    Participants will use the mobile health application for 8 weeks.

    Other: Mobile Health App for Neuropathic Pain Management in MS

  • No intervention
    Arm 2 Name: Standard Care Group (Control)

    Participants will receive standard care without the mobile health application.

Interventions

  • OtherMobile 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks after intervention start

  2. 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.

    Time frame: Baseline and 8 weeks after intervention start

  3. 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.

    Time frame: Baseline and 8 weeks after intervention start

Secondary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks after intervention start

  2. 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.

    Time frame: Baseline and 8 weeks after intervention start

  3. 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.

    Time frame: Baseline and 8 weeks after intervention start

  4. 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.

    Time frame: Baseline and 8 weeks after intervention start

07

Study locations

1 site
  • Uskudar University, Faculty of Health Sciences
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2025 to primary completion in Oct 2025, 2 months.

Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 2 months is below that.

Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

Start moved once since we started tracking on Sep 25, 2026: Jul 2025 → Aug 2025, on Oct 27, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2025
First posted
May 21, 2025
StartActual
Aug 20, 2025was Jul 2025
Primary completionActual
Oct 30, 2025
CompletionActual
Dec 30, 2025
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Oct 27, 2026
Start date
Jul 1, 2025→Aug 20, 2025 (actual)
Oct 27, 2026
Primary completion
Oct 1, 2025→Oct 30, 2025 (actual)
Oct 27, 2026
Study completion
Dec 15, 2025→Dec 30, 2025 (actual)
Oct 27, 2026
Enrollment
52 (estimated)→56 (actual)
Oct 27, 2026
Eligibility
Criteria largely rewritten (29 changes)
What changed in the criteria
  • AddedInclusion criteria
  • EditedBeingAged 18 years of age or older,
  • EditedHaving a definitiveDefinite diagnosis of MSmultiple sclerosis according to the 2017 McDonald 2017 criteria,
  • EditedHaving an Expanded Disability Status Scale (EDSS) score ≤ 5*,5.5, assessed by a neurologist
  • AddedNeuropathic pain confirmed by a Douleur Neuropathique 4 score ≥4 and a painDETECT score ≥19
  • AddedPain severity ≥1 on a Visual Analogue Scale
  • AddedBeck Depression Inventory score <17
  • AddedOwnership of an Android smartphone
  • AddedLiterate in Turkish
  • AddedNo neurological symptoms impeding smartphone use
  • AddedWilling to provide written informed consent Exclusion criteria
  • Added1 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
Inclusion criteria
  • RemovedOwning a smartphone with an Android operating system,
  • RemovedBeing able to communicate in Turkish,
  • RemovedBeing literate,
  • RemovedNo neurological symptoms that could impair smartphone use (e.g., tremor),
  • RemovedPain Detect Pain Questionnaire score of 19 or higher,
  • RemovedNeuropathic Pain Questionnaire score of 4 or higher,
  • RemovedBeck Depression Scale score below 17, *EDSS scores determined by a physician's evaluation will be considered.
Exclusion criteria
  • RemovedHaving undergone surgical interventions on the musculoskeletal system (for at least six months),
  • RemovedHaving a known neurological disorder (epilepsy, dementia)*,
  • RemovedHaving vision or hearing problems that could affect test performance*,
  • RemovedChronic pain not attributable to neuropathic causes (cancer, carpal tunnel syndrome, postherpetic neuralgia)*,
  • RemovedPeripheral vascular complications due to diabetes or other etiologies*,
  • RemovedParticipation in supervised exercise, home exercise, group exercise, etc., as part of physical therapy*,
  • RemovedParticipation in psychological therapies (cognitive and/or behavioral therapy, biofeedback), *
  • RemovedParticipation in mind-body practices (yoga, tai chi, etc.),*
  • RemovedParticipation in acupuncture, *
  • RemovedReceiving invasive treatments (e.g., injections, nerve blocks, spinal cord stimulators, parenteral medications, etc.) *, * Patient self-report and medical records will be used as the basis for inclusion; patients with observed vision or hearing impairments during testing will be excluded from the study.
Oct 27, 2026
Primary outcomes
1 edited, 2 added
What changed in the outcomes
  • EditedReductionChange in Neuropathic Pain IntensitySeverity Measured by the Visual AnalogAnalogue Scale (VAS)Time frame: Baseline and 8 weeks after intervention start
  • AddedChange in Physical Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54Time frame: Baseline and 8 weeks after intervention start
  • AddedChange in Mental Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54Time frame: Baseline and 8 weeks after intervention start
Oct 27, 2026
Secondary outcomes
4 added, 1 removed
What changed in the outcomes
  • AddedChange in Fatigue Measured by the Fatigue Severity ScaleTime frame: Baseline and 8 weeks after intervention start
  • AddedChange in Insomnia Severity Measured by the Insomnia Severity IndexTime frame: Baseline and 8 weeks after intervention start
  • AddedChange in Health-Promoting Lifestyle Behaviours Measured by the Health-Promoting Lifestyle Profile IITime frame: Baseline and 8 weeks after intervention start
  • AddedChange in Self-Management Measured by the Multiple Sclerosis Self-Management ScaleTime frame: Baseline and 8 weeks after intervention start
  • RemovedImprovement in Quality of Life Measured by Multiple Sclerosis Quality of Life-54 (MSQOL-54)Time frame: Baseline and 8 weeks after intervention start
Oct 27, 2026
Sponsor
Collaborators added: The Scientific and Technological Research Council of Turkey; collaborators removed: The Scientific and Technological Research Council of Türkiye (TÜBİTAK)
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Completed
    Start date Jul 1, 2025→Aug 20, 2025 (now actual)
    Primary completion Oct 1, 2025→Oct 30, 2025 (now actual)
    Study completion Dec 15, 2025→Dec 30, 2025 (now actual)
    Enrollment 52 (estimated)→56 (actual)
    Eligibility Criteria largely rewritten (29 changes)
    What changed in the criteria
    • AddedInclusion criteria
    • EditedBeingAged 18 years of age or older,
    • EditedHaving a definitiveDefinite diagnosis of MSmultiple sclerosis according to the 2017 McDonald 2017 criteria,
    • EditedHaving an Expanded Disability Status Scale (EDSS) score ≤ 5*,5.5, assessed by a neurologist
    • AddedNeuropathic pain confirmed by a Douleur Neuropathique 4 score ≥4 and a painDETECT score ≥19
    • AddedPain severity ≥1 on a Visual Analogue Scale
    • AddedBeck Depression Inventory score <17
    • AddedOwnership of an Android smartphone
    • AddedLiterate in Turkish
    • AddedNo neurological symptoms impeding smartphone use
    • AddedWilling to provide written informed consent Exclusion criteria
    • Added1 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
    Inclusion criteria
    • RemovedOwning a smartphone with an Android operating system,
    • RemovedBeing able to communicate in Turkish,
    • RemovedBeing literate,
    • RemovedNo neurological symptoms that could impair smartphone use (e.g., tremor),
    • RemovedPain Detect Pain Questionnaire score of 19 or higher,
    • RemovedNeuropathic Pain Questionnaire score of 4 or higher,
    • RemovedBeck Depression Scale score below 17, *EDSS scores determined by a physician's evaluation will be considered.
    Exclusion criteria
    • RemovedHaving undergone surgical interventions on the musculoskeletal system (for at least six months),
    • RemovedHaving a known neurological disorder (epilepsy, dementia)*,
    • RemovedHaving vision or hearing problems that could affect test performance*,
    • RemovedChronic pain not attributable to neuropathic causes (cancer, carpal tunnel syndrome, postherpetic neuralgia)*,
    • RemovedPeripheral vascular complications due to diabetes or other etiologies*,
    • RemovedParticipation in supervised exercise, home exercise, group exercise, etc., as part of physical therapy*,
    • RemovedParticipation in psychological therapies (cognitive and/or behavioral therapy, biofeedback), *
    • RemovedParticipation in mind-body practices (yoga, tai chi, etc.),*
    • RemovedParticipation in acupuncture, *
    • RemovedReceiving invasive treatments (e.g., injections, nerve blocks, spinal cord stimulators, parenteral medications, etc.) *, * Patient self-report and medical records will be used as the basis for inclusion; patients with observed vision or hearing impairments during testing will be excluded from the study.
    Primary outcomes 1 edited, 2 added
    What changed in the outcomes
    • EditedReductionChange in Neuropathic Pain IntensitySeverity Measured by the Visual AnalogAnalogue Scale (VAS)Time frame: Baseline and 8 weeks after intervention start
    • AddedChange in Physical Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54Time frame: Baseline and 8 weeks after intervention start
    • AddedChange in Mental Health-Related Quality of Life Measured by the Multiple Sclerosis Quality of Life-54Time frame: Baseline and 8 weeks after intervention start
    Secondary outcomes 4 added, 1 removed
    What changed in the outcomes
    • AddedChange in Fatigue Measured by the Fatigue Severity ScaleTime frame: Baseline and 8 weeks after intervention start
    • AddedChange in Insomnia Severity Measured by the Insomnia Severity IndexTime frame: Baseline and 8 weeks after intervention start
    • AddedChange in Health-Promoting Lifestyle Behaviours Measured by the Health-Promoting Lifestyle Profile IITime frame: Baseline and 8 weeks after intervention start
    • AddedChange in Self-Management Measured by the Multiple Sclerosis Self-Management ScaleTime frame: Baseline and 8 weeks after intervention start
    • RemovedImprovement in Quality of Life Measured by Multiple Sclerosis Quality of Life-54 (MSQOL-54)Time frame: Baseline and 8 weeks after intervention start
    Sponsor Collaborators added: The Scientific and Technological Research Council of Turkey; collaborators removed: The Scientific and Technological Research Council of Türkiye (TÜBİTAK)
    + 6 other changes: index terms, verification date, oversight details, design details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06982742
Lead sponsor
Meryem Kocaslan Toran
Collaborators
Uskudar University, The Scientific and Technological Research Council of Turkey
Responsible party
Meryem Kocaslan Toran (Principal investigator, Uskudar University) — Sponsor-investigator
First posted
May 21, 2025
Start date
Aug 20, 2025
Primary completion
Oct 30, 2025
Completion
Dec 30, 2025
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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