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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Bensu Ayaz Haytaoğlu, MD
- 電話番号：+90 552 252 56 16
- メール：bensuayaz@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：CROSS_SECTIONAL
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Thoracolumbar Fascia Thickness Assessed by Ultrasonography
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disability Assessed by the Oswestry Disability Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Pelin Yıldırım, MD、Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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