Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis
Association Between Sarcopenia and Outcomes of Interlaminar Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis: A Prospective Observational Study
This prospective observational study aims to investigate the association between sarcopenia and clinical outcomes following interlaminar epidural steroid injection in patients with lumbar spinal stenosis.
Patients who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care will be enrolled. Before the procedure, sarcopenia-related assessments, including the SARC-F questionnaire, handgrip strength, and the five-times sit-to-stand test, will be performed. Lumbar magnetic resonance imaging (MRI) will also be evaluated for paraspinal muscle characteristics and the severity of lumbar spinal stenosis.
Pain intensity, functional status, walking capacity, and health-related quality of life will be assessed at baseline. Pain intensity, functional status, and health-related quality of life will be reassessed at 3 weeks and 3 months after the procedure. The study will evaluate whether sarcopenia and MRI-based paraspinal muscle characteristics are associated with clinical outcomes following interlaminar epidural steroid injection.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Konuralp Karbeyaz
- Telefonszám: +90 216 625 45 45
- E-mail: nurbanuhindioglu@gmail.com
Tanulmányi helyek
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Istanbul
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Istanbul, Istanbul, Törökország (Türkiye), 34899
- Toborzás
- Marmara University Pendik Training and Research Hospital
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Kapcsolatba lépni:
- Konuralp Karbeyaz
- Telefonszám: +90 216 625 45 45
- E-mail: nurbanuhindioglu@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
The study population will consist of patients aged 50-75 years with clinically and radiologically diagnosed lumbar spinal stenosis who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care due to persistent symptoms despite conservative treatment. Participants will be classified according to sarcopenia status based on baseline assessments and followed for 3 months.
Leírás
Inclusion Criteria:
- Clinical and radiological diagnosis of lumbar spinal stenosis
- Persistent symptoms despite conservative treatment and scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care
- Age between 50 and 75 years
- Low back and/or leg pain for at least 3 months
- Availability of lumbar magnetic resonance imaging (MRI)
Exclusion Criteria:
- History of lumbar fusion surgery
- Lumbar epidural steroid injection within the previous 3 months
- Prominent radiculopathy due to lumbar disc herniation
- Severe motor deficit or an indication for surgical treatment
- Polyneuropathy, neuromuscular disease, or neurological disease that may significantly affect muscle mass
- Active malignancy or systemic inflammatory disease
- Significant mobility limitation due to advanced hip or knee osteoarthritis
- Cognitive impairment or communication problems that may prevent completion of study assessments
- Coagulopathy or active infection constituting a contraindication to epidural injection
- Inflammatory rheumatic disease requiring chronic corticosteroid therapy
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
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Patients with Sarcopenia
Patients with lumbar spinal stenosis who meet the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria for probable sarcopenia based on reduced muscle strength at baseline and who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care. |
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Patients without Sarcopenia
Patients with lumbar spinal stenosis who do not meet the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria for probable sarcopenia based on muscle strength assessment at baseline and who are scheduled to undergo interlaminar epidural steroid injection as part of routine clinical care. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Időkeret: Baseline, 3 weeks, and 3 months
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Leg pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. NRS scores will be recorded at baseline, 3 weeks, and 3 months. Changes in leg pain intensity from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Időkeret: Baseline, 3 weeks, and 3 months
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Low back pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. NRS scores will be recorded at baseline, 3 weeks, and 3 months. Changes in low back pain intensity from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Időkeret: Baseline, 3 weeks, and 3 months
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Functional disability will be assessed using the Istanbul Low Back Pain Disability Index (ILBPDI). The ILBPDI consists of 18 items and has a total score ranging from 0 to 90, with higher scores indicating greater disability. ILBPDI scores will be recorded at baseline, 3 weeks, and 3 months. Changes from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Időkeret: Baseline, 3 weeks, and 3 months
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Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12), which provides Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Both scores range from 0 to 100, with higher scores indicating better health-related quality of life. Scores will be recorded at baseline, 3 weeks, and 3 months. Changes from baseline will be compared between patients with and without sarcopenia. |
Baseline, 3 weeks, and 3 months
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Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome
Időkeret: Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
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Erector spinae cross-sectional area (CSA) will be measured on baseline lumbar magnetic resonance imaging (MRI) in square centimeters (cm²). Leg pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity. The correlation between baseline erector spinae CSA and change in leg pain NRS from baseline will be evaluated. |
Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 09.2026.878
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
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