Lumbar Disc DiseaseFascia-MNCT07060235
Development of a Fascial Training Based Mobile Application and Investigation of Its Effectiveness in Patients With Disc Herniation
A study testing fascial exercise home brochure, Fascial exercise based mobile application and lumbal stabilizasyon home brochure in people with Lumbar Disc Disease and Lumbal Disc Herniation, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study will compare three different groups for lumbar disc herniation. The first group will do fascia exercises via a mobile application, the second group will do fascia exercises via a home leaflet, and the third group will do lumbar stabilization exercises via a home leaflet. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Lumbar Disc Disease, Lumbal Disc Herniation
- What is being tested?
- fascial exercise home brochure, Fascial exercise based mobile application and lumbal stabilizasyon home brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Mobile on Android devices have the competence to use the application
- No neurological deficit
- painkillers during the treatment process
- They are volunteer individuals who do not use medication
- İnclusion Criteria:
- speak Turkish, and have Turkish literacy.
Show all 11Show fewer
- included lumbar
- diagnosed with disc herniation with doctor's diagnosis
- participants is between the ages of 20-55,
- able to use mobile technology
- willing to participate in the study individuals with
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Lumbal Disk Hernili Hastalarda Fasyal Egzersiz Tabanlı Mobil Uygulama Geliştirilmesi ve Etkinliğinin Araştırılması
This study will compare three different groups for lumbar disc herniation. The first group will do fascia exercises via a mobile application, the second group will do fascia exercises via a home leaflet, and the third group will do lumbar stabilization exercises via a home leaflet. Since there is not yet a mobile application that includes fascia exercises, this application will be made available to patients for home use after it is developed during the study.
The physiotherapist will teach the exercises in the clinical setting in three different groups.
Read the detailed description
In the study, 20 people in three different groups with a drop-out rate of twenty percent will participate in the study. This number is 60 people in total.
In the study, fascia exercises will be applied at home with the mobile application named Fascia-M for the first group, fascia exercises will be applied at home with the home brochure for the second group, and lumbar stabilization exercises will be applied at home with the home brochure for the third group. Visual pain scale, Tampa kinesiophobia scale, SF-12 Quality of Life Questionnaire, Pittsburg Sleep Quality Scale, modified schober test, digital inclinometer measurements will be applied and evaluated by the physiotherapist before and after the study.
- Conditions
- Lumbar Disc Disease, Lumbal Disc Herniation
- Being tested
- fascial exercise home brochure, Fascial exercise based mobile application, lumbal stabilizasyon home brochure
- Keywords
- fascia, mobile app, disc herniation
- Medical subject headings
- Intervertebral disc disease, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascial exercise home brochureOther
Fascia exercises are taught by the physiotherapist in the clinical setting and if the exercises are performed incorrectly, intervention is made and the correct exercise is taught. At home, the individual is motivated and monitored with an exercise diary. He/she remembers the exercises from the home brochure.
Fascial exercise based mobile applicationOther
Fascia exercises are taught by the physiotherapist in the clinical setting and if the exercises are performed incorrectly, intervention is made and the correct exercise is taught. At home, the individual is motivated and monitored with an exercise diary. Performs the exercises by watching videos on the mobile application. The physiotherapist intervenes in motivation with instant notifications via the mobile application.
lumbal stabilizasyon home brochureOther
Participants assigned to the intervention group will receive a structured home-based lumbar stabilization exercise program designed to improve spinal stability, core muscle control, and functional performance. The program will target deep trunk stabilizer muscles, including the transversus abdominis and multifidus, through low-load, motor control-based exercises.
The intervention will last for 14 days, with exercises to be performed 3 times for everyday, Each session will last approximately 20-30 minutes and consist of:
Warm-up (1 minutes): Breathing exercises and gentle mobility
Core Stabilization (15-20 minutes): Exercises such as abdominal hollowing, bridging, bird-dog, side plank, and dead bug - progressing from static holds to dynamic movements as tolerated
Cool-down (1 minutes): Light stretching and relaxation
| Study group | Role | What they receive |
|---|---|---|
| Fascial exercise | Active comparator | Fascial exercises are a systematic set of movements and manual techniques that target the fascia-the body's connective tissue network-with the aim of improving or maintaining its elasticity, hydration, mobility, and functional integrity. These exercises seek to enhance gliding between fascial layers, reduce tissue restrictions, improve neuromuscular coordination, and alleviate chronic musculoskeletal pain.Fascia is not merely a passive structure; it functions as an active sensory organ containing proprioceptors, nociceptors, and mechanoreceptors.
This exercise system will first be taught to the patient by a physiotherapist, then a home brochure will be given and the patient will be given 14 days to practice it at home. Receives: Other: fascial exercise home brochure |
| Fascial exercise based mobile application | Active comparator | Individuals in this arm will do fascia exercises at home through a mobile application as home exercises. These exercises would be taught to the participant by the physiotherapist in the clinical setting and then the participant would be allowed to install a mobile application on their phone. The name of this mobile application is Fascia-M. This mobile application will be developed by the researcher of this study during the study process. Receives: Other: Fascial exercise based mobile application |
| lumbal stabilization | Active comparator | Within the scope of this study, lumbar stabilization exercises will be applied to a specific group of participants within a home-based exercise program. The program is structured to support individuals' activities of daily living, maintain spinal health and improve muscle balance in the lumbar region. Lumbar stabilization exercises consist of controlled movements that target the deep spinal stabilizer muscles (especially m. transversus abdominis and m. multifidus) and contribute to maintaining the spine in a neutral position. Receives: Other: lumbal stabilizasyon home brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a Fascial Exercise Based Mobile Application and Investigation of Its Effectiveness in Patients with Disc Herniation
Change in self-reported low back pain intensity as measured by the Visual Analog Scale (VAS). The VAS is a unidimensional pain assessment tool consisting of a 10 cm horizontal line anchored by "no pain" (0 cm) and "worst imaginable pain" (10 cm). Participants will mark their current pain level on the line. The distance (in cm) from the left end to the mark will be recorded as the pain score.
Measured: 14 days after the start of the exercise programme
Secondary outcomes (1)
Development of a Fascial Exercise Based Mobile Application and Investigation of Its Effectiveness in Patients with Disc Herniation
Change in lumbar functional disability assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections measuring the degree of disability in daily living activities due to low back pain. Total scores range from 0% (no disability) to 100% (maximum disability).
Measured: 14 days after the start of exercise programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Feb 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060235
- Sponsor's protocol ID
- BaskentU-FTR-FA-02
- Acronym
- Fascia-M
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbal Disk Hernili Hastalarda Fasyal Egzersiz Tabanlı Mobil Uygulama Geliştirilmesi ve Etkinliğinin Araştırılması
- ClinicalTrials.gov ID
- NCT07060235
- Acronym / sponsor ID
- Fascia-M / BaskentU-FTR-FA-02
- Conditions
- Lumbar Disc Disease, Lumbal Disc Herniation
- Keywords
- fascia, mobile app, disc herniation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 11 Jul 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.
This study will compare three different groups for lumbar disc herniation. The first group will do fascia exercises via a mobile application, the second group will do fascia exercises via a home leaflet, and the third group will do lumbar stabilization exercises via a home leaflet. Since there is not yet a mobile application that includes fascia exercises, this application will be made available to patients for home use after it is developed during the study.
The physiotherapist will teach the exercises in the clinical setting in three different groups.
Detailed description
In the study, 20 people in three different groups with a drop-out rate of twenty percent will participate in the study. This number is 60 people in total.
In the study, fascia exercises will be applied at home with the mobile application named Fascia-M for the first group, fascia exercises will be applied at home with the home brochure for the second group, and lumbar stabilization exercises will be applied at home with the home brochure for the third group. Visual pain scale, Tampa kinesiophobia scale, SF-12 Quality of Life Questionnaire, Pittsburg Sleep Quality Scale, modified schober test, digital inclinometer measurements will be applied and evaluated by the physiotherapist before and after the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fascial exercise | Active comparator | Other: fascial exercise home brochureFascial exercises are a systematic set of movements and manual techniques that target the fascia-the body's connective tissue network-with the aim of improving or maintaining its elasticity, hydration, mobility, and functional integrity. These exercises seek to enhance gliding between fascial layers, reduce tissue restrictions, improve neuromuscular coordination, and alleviate chronic musculoskeletal pain.Fascia is not merely a passive structure; it functions as an active sensory organ containing proprioceptors, nociceptors, and mechanoreceptors. This exercise system will first be taught to the patient by a physiotherapist, then a home brochure will be given and the patient will be given 14 days to practice it at home. |
| Fascial exercise based mobile application | Active comparator | Other: Fascial exercise based mobile applicationIndividuals in this arm will do fascia exercises at home through a mobile application as home exercises. These exercises would be taught to the participant by the physiotherapist in the clinical setting and then the participant would be allowed to install a mobile application on their phone. The name of this mobile application is Fascia-M. This mobile application will be developed by the researcher of this study during the study process. |
| lumbal stabilization | Active comparator | Other: lumbal stabilizasyon home brochureWithin the scope of this study, lumbar stabilization exercises will be applied to a specific group of participants within a home-based exercise program. The program is structured to support individuals' activities of daily living, maintain spinal health and improve muscle balance in the lumbar region. Lumbar stabilization exercises consist of controlled movements that target the deep spinal stabilizer muscles (especially m. transversus abdominis and m. multifidus) and contribute to maintaining the spine in a neutral position. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Mobile on Android devices have the competence to use the application
- No neurological deficit
- painkillers during the treatment process
- They are volunteer individuals who do not use medication
- speak Turkish, and have Turkish literacy.
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 |
|---|---|---|
| fascial exercise home brochureFascia exercises are taught by the physiotherapist in the clinical setting and if the exercises are performed incorrectly, intervention is made and the correct exercise is taught. At home, the individual is motivated and monitored with an exercise diary. He/she remembers the exercises from the home brochure. | Other | Fascial exercise |
| Fascial exercise based mobile applicationFascia exercises are taught by the physiotherapist in the clinical setting and if the exercises are performed incorrectly, intervention is made and the correct exercise is taught. At home, the individual is motivated and monitored with an exercise diary. Performs the exercises by watching videos on the mobile application. The physiotherapist intervenes in motivation with instant notifications via the mobile application. | Other | Fascial exercise based mobile application |
| lumbal stabilizasyon home brochureParticipants assigned to the intervention group will receive a structured home-based lumbar stabilization exercise program designed to improve spinal stability, core muscle control, and functional performance. The program will target deep trunk stabilizer muscles, including the transversus abdominis and multifidus, through low-load, motor control-based exercises. The intervention will last for 14 days, with exercises to be performed 3 times for everyday, Each session will last approximately 20-30 minutes and consist of: Warm-up (1 minutes): Breathing exercises and gentle mobility Core Stabilization (15-20 minutes): Exercises such as abdominal hollowing, bridging, bird-dog, side plank, and dead bug - progressing from static holds to dynamic movements as tolerated Cool-down (1 minutes): Light stretching and relaxation | Other | lumbal stabilization |
Primary outcome
Development of a Fascial Exercise Based Mobile Application and Investigation of Its Effectiveness in Patients with Disc Herniation
Time frame: 14 days after the start of the exercise programme
Change in self-reported low back pain intensity as measured by the Visual Analog Scale (VAS). The VAS is a unidimensional pain assessment tool consisting of a 10 cm horizontal line anchored by "no pain" (0 cm) and "worst imaginable pain" (10 cm). Participants will mark their current pain level on the line. The distance (in cm) from the left end to the mark will be recorded as the pain score.
1 secondary outcome
Development of a Fascial Exercise Based Mobile Application and Investigation of Its Effectiveness in Patients with Disc Herniation
Time frame: 14 days after the start of exercise programme
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- fascial fıtnessLink provided by the sponsor.
- 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.
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 fascial exercise home brochure, Fascial exercise based mobile application and lumbal stabilizasyon home brochure in people with Lumbar Disc Disease and Lumbal Disc Herniation, run by Baskent University 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 0 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 23 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Development of a Fascial Exercise Based Mobile Application and Investigation of Its Effectiveness in Patients with Disc Herniation (time frame: 14 days after the start of the exercise programme). 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 23 Sep 2025.