Low Back PainNCT07031947
The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chronic Low Back Pain
A study testing Core stabilization exercise with telerehabilitation and Face-to-face core stabilization exercise in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain and Core Muscle
- What is being tested?
- Core stabilization exercise with telerehabilitation and Face-to-face core stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 20 and 60 years of age Non-specific low back pain lasting more than 3 months (VAS > 2) No neurological deficits such as abnormal sensation, loss of muscle strength, or loss of reflexes in the lower extremity No indication for surgery Able to attend treatment 3 days a week for 8 weeks
Who cannot join
- Participating in a physical therapy or exercise program in the last 3 months Previous surgery, dislocation, or fracture in the lumbar region Rheumatic / autoimmune disease Serious cardiovascular disease, progressive neurological deficit, severe osteoporosis, or metabolic diseases Having a systemic disease that can cause back pain Pregnancy or lactation Uncontrolled hypertension Having problems perceiving verbal commands Not having internet access Not having equipment to make video calls at home Not having a device at home to use the application
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
About this study
Official title: The Effect of Core Stabilization Exercise Program Applied With Telerehabilitation Method in Virtual Reality Environment in the Treatment of Patients With Chronic Non-Specific Low Back Pain: A Single-Blind Randomized Controlled Study
A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1, 2025, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. After the patients are informed verbally and in writing about the purpose, duration and application method of the study and their consent is obtained, they will be asked to sign the "Informed Consent Form". Patient evaluation and follow-up forms will be filled out during pre-treatment and post-treatment follow-ups. After patients who meet the study inclusion criteria are included in the study, they will be numbered according to the order of application and then randomly assigned to the intervention group or control group by a computer program into 2 groups.
In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks.
The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain and Core Muscle, Core Stabilization Exercise Therapy
- Being tested
- Core stabilization exercise with telerehabilitation, Face-to-face core stabilization exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercise with telerehabilitationOther
In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks.
Face-to-face core stabilization exerciseOther
The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Active comparator | Not described Receives: Other: Core stabilization exercise with telerehabilitation |
| Face-to-face rehabilitation group | Other | Not described Receives: Other: Face-to-face core stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Index
It is a commonly used and validated scale for measuring disability in low back pain. It consists of a total of 10 questions. Each question is scored on a scale of 0 to 5. Higher scores indicate worse symptoms or functioning.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Visuel Analog Scale
The severity of pain before treatment is assessed using the Visual Analog Scale (VAS), a 10 cm long line with "no pain" on the left end and "unbearable pain" on the right end. The distance in centimeters between the point marked by the patient and the 0 point is measured. The average pain level before and after treatment will be evaluated using the VAS, scored between 0 and 10; 0 indicates no pain, and 10 indicates the worst possible pain.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Secondary outcomes (4)
Roland Morris Disability Questionnaire
It is a validated scale used to measure disability in low back pain. The total score ranges from 0 (no disability) to 24 (severe disability). A higher total score indicates decreased patient functionality. Higher scores reflect worse symptoms or function.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Tampa Kinesiophobia Fatigue Scale
The Tampa Scale for Kinesiophobia is a 17-item tool used to assess fear of movement. A 4-point Likert scoring system is used in the questionnaire. Items 4, 8, 12, and 16 are reverse scored, and the total score is calculated by summing all items. The total score ranges from 17 to 68. A higher score on the scale indicates a higher level of kinesiophobia.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Measurement of Bilateral Lumbar Multifidus and Transversus Abdominis Muscle Thickness with Ultrasound Imaging
Ultrasonographic evaluation will be performed using the Esaote Mylab 60 device. The resting muscle thickness of the lumbar multifidus will be measured longitudinally with a convex probe at the L4-L5 facet level at the end of expiration while the patient is in the prone position. After the contralateral arm-raising maneuver, the contracted thickness of the multifidus will be measured at the same level.
The transversus abdominis measurement will be performed at the end of expiration in the supine position, with knees bent, heels resting on the table, and hands placed under the head. A linear probe will be used at the midpoint between the 12th rib and the iliac crest, 2.5 cm anterior to the mid-axillary line. Following the ipsilateral straight leg raise maneuver, the contracted transversus abdominis thickness will be measured at the same level.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Assessment of Trunk Muscle Strength with Computerized Isokinetic Dynamometer
In our study, trunk extensor and flexor muscle strengths will be measured with a Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) computerized isokinetic dynamometer machine. Maximum strength will be used to perform trunk extension and flexion at speeds of 60°/s, 90°/s, and 120°/s, respectively, with 5 repetitions at each speed. Peak torque and total work values of the participants will be recorded.
Measured: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Emre Öney, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031947
- Sponsor's protocol ID
- E-29624016-050.04-2603725
- Status last verified
- Mar 2026
- First submitted
- 1 Jun 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Exercise Program Applied With Telerehabilitation Method in Virtual Reality Environment in the Treatment of Patients With Chronic Non-Specific Low Back Pain: A Single-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07031947
- Acronym / sponsor ID
- E-29624016-050.04-2603725
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain and Core Muscle, Core Stabilization Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 22 Jun 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.
A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1, 2025, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. After the patients are informed verbally and in writing about the purpose, duration and application method of the study and their consent is obtained, they will be asked to sign the "Informed Consent Form". Patient evaluation and follow-up forms will be filled out during pre-treatment and post-treatment follow-ups. After patients who meet the study inclusion criteria are included in the study, they will be numbered according to the order of application and then randomly assigned to the intervention group or control group by a computer program into 2 groups.
In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks.
The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Active comparator | Other: Core stabilization exercise with telerehabilitation |
| Face-to-face rehabilitation group | Other | Other: Face-to-face core stabilization exercise |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between 20 and 60 years of age Non-specific low back pain lasting more than 3 months (VAS > 2) No neurological deficits such as abnormal sensation, loss of muscle strength, or loss of reflexes in the lower extremity No indication for surgery Able to attend treatment 3 days a week for 8 weeks
Key exclusion criteria (1 listed)
- Participating in a physical therapy or exercise program in the last 3 months Previous surgery, dislocation, or fracture in the lumbar region Rheumatic / autoimmune disease Serious cardiovascular disease, progressive neurological deficit, severe osteoporosis, or metabolic diseases Having a systemic disease that can cause back pain Pregnancy or lactation Uncontrolled hypertension Having problems perceiving verbal commands Not having internet access Not having equipment to make video calls at home Not having a device at home to use the application
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 |
|---|---|---|
| Core stabilization exercise with telerehabilitationIn addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks. | Other | Telerehabilitation Group |
| Face-to-face core stabilization exerciseThe control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people. | Other | Face-to-face rehabilitation group |
Primary outcome
Oswestry Low Back Pain Disability Index
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
It is a commonly used and validated scale for measuring disability in low back pain. It consists of a total of 10 questions. Each question is scored on a scale of 0 to 5. Higher scores indicate worse symptoms or functioning.
Visuel Analog Scale
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
The severity of pain before treatment is assessed using the Visual Analog Scale (VAS), a 10 cm long line with "no pain" on the left end and "unbearable pain" on the right end. The distance in centimeters between the point marked by the patient and the 0 point is measured. The average pain level before and after treatment will be evaluated using the VAS, scored between 0 and 10; 0 indicates no pain, and 10 indicates the worst possible pain.
4 secondary outcomes
Roland Morris Disability Questionnaire
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Tampa Kinesiophobia Fatigue Scale
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Measurement of Bilateral Lumbar Multifidus and Transversus Abdominis Muscle Thickness with Ultrasound Imaging
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
Assessment of Trunk Muscle Strength with Computerized Isokinetic Dynamometer
Time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Core stabilization exercise with telerehabilitation and Face-to-face core stabilization exercise in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 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?
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?
Oswestry Low Back Pain Disability Index (time frame: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)). The study lists 2 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 Mar 2026.