Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 2 trial groupsGroup A: Patients with Sarcopenia
Group B: Patients without Sarcopenia
Trial outcomes
Primary outcomes
1
Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
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.
Time frame
Baseline, 3 weeks, and 3 monthsSecondary outcomes
1
Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
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.
Time frame
Baseline, 3 weeks, and 3 months2
Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
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.
Time frame
Baseline, 3 weeks, and 3 months3
Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
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.
Time frame
Baseline, 3 weeks, and 3 months4
Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome
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.
Time frame
Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov