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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Bensu Ayaz Haytaoğlu, MD
- 전화번호: +90 552 252 56 16
- 이메일: bensuayaz@gmail.com
참여기준
자격 기준
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건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
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디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: CROSS_SECTIONAL
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Thoracolumbar Fascia Thickness Assessed by Ultrasonography
기간: At baseline (single assessment)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disability Assessed by the Oswestry Disability Index
기간: 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)
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Pain Intensity Assessed by the Visual Analog Scale
기간: 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)
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Neuropathic Pain Assessment Using the DN4 Questionnaire
기간: 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)
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Hamstring Flexibility Assessed by the Passive Knee Extension Test
기간: 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)
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Ultrasonographic Morphological Characteristics of the Thoracolumbar Fascia
기간: 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)
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Paravertebral Muscle Trophism Assessed by Ultrasonography
기간: 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)
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Paravertebral Muscle Fatty Infiltration on Lumbar MRI
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pelin Yıldırım, MD, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
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추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .