An observational study in Intervertebral Disc Degeneration, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Not yet recruiting. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 90 is below the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Presence of scoliosis, spondylolisthesis, or severe osteoporosis.
History of trauma or vertebral fracture.
Rheumatologic diseases, including rheumatoid arthritis or ankylosing spondylitis.
Neurological diseases.
or infection.
Modic type 3 changes on lumbar MRI.
Pregnancy or breastfeeding.
Cognitive impairment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: At baseline (single assessment)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline (single assessment)
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital