NCT07060235

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

February 6, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

fasciamobile appdisc herniation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    14 days after the start of exercise programme

Study Arms (3)

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.

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.

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.

Other: lumbal stabilizasyon home brochure

Interventions

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

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.

Fascial exercise based mobile application

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

lumbal stabilization

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent Universty

Ankara, 06790, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Intervertebral disc diseaseIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

July 11, 2025

Study Start

February 1, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

December 15, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

statics (fascial tarining)Access

Locations