- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07917663
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
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.
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Bensu Ayaz Haytaoğlu, MD
- Telefonnummer: +90 552 252 56 16
- E-post: bensuayaz@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Modic type 3 changes on lumbar MRI.
Pregnancy or breastfeeding.
Cognitive impairment.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: CROSS_SECTIONAL
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thoracolumbar Fascia Thickness Assessed by Ultrasonography
Tidsram: 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). |
At baseline (single assessment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disability Assessed by the Oswestry Disability Index
Tidsram: At baseline (single assessment)
|
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. |
At baseline (single assessment)
|
|
Pain Intensity Assessed by the Visual Analog Scale
Tidsram: At baseline (single assessment)
|
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. |
At baseline (single assessment)
|
|
Neuropathic Pain Assessment Using the DN4 Questionnaire
Tidsram: At baseline (single assessment)
|
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. |
At baseline (single assessment)
|
|
Hamstring Flexibility Assessed by the Passive Knee Extension Test
Tidsram: At baseline (single assessment)
|
Hamstring flexibility will be evaluated using the Passive Knee Extension Test. The knee extension angle will be measured in degrees. |
At baseline (single assessment)
|
|
Ultrasonographic Morphological Characteristics of the Thoracolumbar Fascia
Tidsram: At baseline (single assessment)
|
Bilateral thoracolumbar fascia morphology will be assessed using ultrasonography and classified into four categories: very disorganized, somewhat disorganized, somewhat organized, and very organized. |
At baseline (single assessment)
|
|
Paravertebral Muscle Trophism Assessed by Ultrasonography
Tidsram: At baseline (single assessment)
|
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. |
At baseline (single assessment)
|
|
Paravertebral Muscle Fatty Infiltration on Lumbar MRI
Tidsram: At baseline (single assessment)
|
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. |
At baseline (single assessment)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Pelin Yıldırım, MD, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026/362
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