- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07060235
- Original Trial
Development of a Fascial Training Based Mobile Application and Investigation of Its Effectiveness in Patients With Disc Herniation (Fascia-M)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ankara, Turkey (Türkiye), 06790
- Başkent Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fascial exercise
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. |
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.
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Active Comparator: Fascial exercise based mobile application
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.
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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.
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Active Comparator: lumbal stabilization
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.
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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14 days after the start of the exercise programme
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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).
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14 days after the start of exercise programme
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BaskentU-FTR-FA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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statics
Information identifier: fascial tariningInformation comments: fascia and mobile app
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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