Intervertebral Disc DegenerationNCT07917663
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
An observational study of Intervertebral Disc Degeneration, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital.
Trial summary
Lumbar intervertebral disc degeneration is a common condition that may be associated with chronic low back pain, reduced spinal flexibility, and limitations in daily activities. Changes in the paravertebral muscles and thoracolumbar fascia may also be related to these symptoms. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Intervertebral Disc Degeneration
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Apr 2027
- Phase
- Observational
- 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 75 years
- Women only
- Adult, Older adult
Study population: The study population will consist of female patients aged 20-75 years presenting to the Physical Medicine and Rehabilitation outpatient clinic of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital with low back pain accompanied by radiating (radicular) leg pain lasting at least 3 months. Eligible patients must have a Visual Analog Scale (VAS) pain score of at least 3, previously acquired lumbar magnetic resonance imaging (MRI) scans, and provide written informed consent. Lumbar MRI scans will be reviewed to assess intervertebral disc degeneration. The study aims to include at least 90 evaluable patients. No healthy control group will be included.
Who may be able to join
- Female patients aged 20-75 years.
- Low back pain with radiating (radicular) leg pain lasting at least 3 months.
- Visual Analog Scale (VAS) pain score of 3 or higher.
- Availability of lumbar magnetic resonance imaging (MRI) scans.
- Voluntary participation and provision of written informed consent.
Who cannot join
- History of spinal or lower extremity surgery.
- Presence of scoliosis, spondylolisthesis, or severe osteoporosis.
- History of trauma or vertebral fracture.
- Rheumatologic diseases, including rheumatoid arthritis or ankylosing spondylitis.
- Neurological diseases.
- Malignancy or infection.
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- Modic type 3 changes on lumbar MRI.
- Pregnancy or breastfeeding.
- Cognitive impairment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Relationship Between Disability, Flexibility, Paravertebral Muscles, and Thoracolumbar Fascia in Patients With Lumbar Intervertebral Disc Degeneration
Lumbar intervertebral disc degeneration is a common condition that may be associated with chronic low back pain, reduced spinal flexibility, and limitations in daily activities. Changes in the paravertebral muscles and thoracolumbar fascia may also be related to these symptoms. However, the relationships among these structural and functional factors are not fully understood.
The aim of this prospective observational study is to investigate the relationships among disability, flexibility, paravertebral muscle characteristics, and thoracolumbar fascia thickness and morphology in patients with lumbar intervertebral disc degeneration.
Read more
The study will include female patients aged 20-75 years with low back pain accompanied by radiating leg pain lasting at least 3 months. Participants will undergo clinical assessments of pain, disability, and lumbar flexibility. Ultrasonography will be used to evaluate thoracolumbar fascia thickness and morphological characteristics, as well as paravertebral muscle trophism. Previously acquired lumbar magnetic resonance imaging (MRI) scans will be reviewed to assess intervertebral disc degeneration, the presence or absence of lumbar disc herniation, and paravertebral muscle characteristics, including fatty infiltration.
The study aims to improve the understanding of the relationships between lumbar spine structural changes, surrounding musculoskeletal tissues, pain, disability, and flexibility. No experimental treatment will be assigned to participants.
- Conditions
- Intervertebral Disc Degeneration
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbar Fascia Thickness Assessed by Ultrasonography
Thoracolumbar fascia thickness will be measured bilaterally using ultrasonography at the L3 vertebral level, 2 cm lateral to the spinous process. Three thickness measurements will be obtained at different points on each ultrasonographic image, and their mean will be calculated. The mean thickness for each side will be recorded separately in millimeters (mm).
Measured: At baseline (single assessment)
Secondary outcomes (7)
Disability Assessed by the Oswestry Disability Index
Disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI). The total score will be expressed as a percentage from 0 to 100, with higher scores indicating greater disability.
Measured: At baseline (single assessment)
Pain Intensity Assessed by the Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: At baseline (single assessment)
Neuropathic Pain Assessment Using the DN4 Questionnaire
Neuropathic pain characteristics will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The total score ranges from 0 to 10, with higher scores indicating more neuropathic pain features.
Measured: At baseline (single assessment)
Hamstring Flexibility Assessed by the Passive Knee Extension Test
Hamstring flexibility will be evaluated using the Passive Knee Extension Test. The knee extension angle will be measured in degrees.
Measured: At baseline (single assessment)
Ultrasonographic Morphological Characteristics of the Thoracolumbar Fascia
Bilateral thoracolumbar fascia morphology will be assessed using ultrasonography and classified into four categories: very disorganized, somewhat disorganized, somewhat organized, and very organized.
Measured: At baseline (single assessment)
Paravertebral Muscle Trophism Assessed by Ultrasonography
Paravertebral muscle trophism will be evaluated using musculoskeletal ultrasonography according to the Galletti classification. Muscle trophism will be classified based on the ultrasonographic profile of the paravertebral muscles.
Measured: At baseline (single assessment)
Paravertebral Muscle Fatty Infiltration on Lumbar MRI
Paravertebral muscle fatty infiltration will be evaluated on previously acquired lumbar magnetic resonance imaging (MRI) scans using the Goutallier classification (grades 0-4). Grade 0 indicates no fatty infiltration; grade 1, fatty streaks; grade 2, less fat than muscle; grade 3, equal amounts of fat and muscle; and grade 4, more fat than muscle. Higher grades indicate greater fatty infiltration.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pelin Yıldırım, MD, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917663
- Sponsor's protocol ID
- 2026/362
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Disability, Flexibility, Paravertebral Muscles, and Thoracolumbar Fascia in Patients With Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT07917663
- Acronym / sponsor ID
- 2026/362
- Conditions
- Intervertebral Disc Degeneration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
Lumbar intervertebral disc degeneration is a common condition that may be associated with chronic low back pain, reduced spinal flexibility, and limitations in daily activities. Changes in the paravertebral muscles and thoracolumbar fascia may also be related to these symptoms. However, the relationships among these structural and functional factors are not fully understood.
The aim of this prospective observational study is to investigate the relationships among disability, flexibility, paravertebral muscle characteristics, and thoracolumbar fascia thickness and morphology in patients with lumbar intervertebral disc degeneration.
The study will include female patients aged 20-75 years with low back pain accompanied by radiating leg pain lasting at least 3 months. Participants will undergo clinical assessments of pain, disability, and lumbar flexibility. Ultrasonography will be used to evaluate thoracolumbar fascia thickness and morphological characteristics, as well as paravertebral muscle trophism. Previously acquired lumbar magnetic resonance imaging (MRI) scans will be reviewed to assess intervertebral disc degeneration, the presence or absence of lumbar disc herniation, and paravertebral muscle characteristics, including fatty infiltration.
The study aims to improve the understanding of the relationships between lumbar spine structural changes, surrounding musculoskeletal tissues, pain, disability, and flexibility. No experimental treatment will be assigned to participants.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of female patients aged 20-75 years presenting to the Physical Medicine and Rehabilitation outpatient clinic of Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital with low back pain accompanied by radiating (radicular) leg pain lasting at least 3 months. Eligible patients must have a Visual Analog Scale (VAS) pain score of at least 3, previously acquired lumbar magnetic resonance imaging (MRI) scans, and provide written informed consent. Lumbar MRI scans will be reviewed to assess intervertebral disc degeneration. The study aims to include at least 90 evaluable patients. No healthy control group will be included.
Key inclusion criteria (5 listed)
- Female patients aged 20-75 years.
- Low back pain with radiating (radicular) leg pain lasting at least 3 months.
- Visual Analog Scale (VAS) pain score of 3 or higher.
- Availability of lumbar magnetic resonance imaging (MRI) scans.
- Voluntary participation and provision of written informed consent.
Key exclusion criteria (9 listed)
- History of spinal or lower extremity surgery.
- Presence of scoliosis, spondylolisthesis, or severe osteoporosis.
- History of trauma or vertebral fracture.
- Rheumatologic diseases, including rheumatoid arthritis or ankylosing spondylitis.
- Neurological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoracolumbar Fascia Thickness Assessed by Ultrasonography
Time frame: At baseline (single assessment)
Thoracolumbar fascia thickness will be measured bilaterally using ultrasonography at the L3 vertebral level, 2 cm lateral to the spinous process. Three thickness measurements will be obtained at different points on each ultrasonographic image, and their mean will be calculated. The mean thickness for each side will be recorded separately in millimeters (mm).
7 secondary outcomes
Disability Assessed by the Oswestry Disability Index
Time frame: At baseline (single assessment)
Pain Intensity Assessed by the Visual Analog Scale
Time frame: At baseline (single assessment)
Neuropathic Pain Assessment Using the DN4 Questionnaire
Time frame: At baseline (single assessment)
Hamstring Flexibility Assessed by the Passive Knee Extension Test
Time frame: At baseline (single assessment)
Ultrasonographic Morphological Characteristics of the Thoracolumbar Fascia
Time frame: At baseline (single assessment)
Paravertebral Muscle Trophism Assessed by Ultrasonography
Time frame: At baseline (single assessment)
Paravertebral Muscle Fatty Infiltration on Lumbar MRI
Time frame: At baseline (single assessment)
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 4 Nov 2026.
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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.
Pelin Yıldırım, MD principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Bensu Ayaz Haytaoğlu, MD (+90 552 252 56 16, bensuayaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar Fascia Thickness Assessed by Ultrasonography (time frame: At baseline (single assessment)). 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 4 Nov 2026.