Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis

NCT07855419 | Not Yet Recruiting

• 1 other identifier: 09.2026.878
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Stenosis Lumbar; Sarcopenia

Keywords

Sarcopenia; Epidural injection; Spinal stenosis

Outcome Measures

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.

  Baseline, 3 weeks, and 3 months

Secondary Outcomes (4)

• Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status

  Baseline, 3 weeks, and 3 months

• Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status

  Baseline, 3 weeks, and 3 months

• Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status

  Baseline, 3 weeks, and 3 months

• Association Between MRI-Based Paraspinal Muscle Characteristics and Clinical Outcomes

  Baseline Magnetic Resonance Imaging; clinical outcomes at 3 weeks and 3 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Spinal Stenosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Konuralp Karbeyaz

CONTACT

+90 216 625 45 45; nurbanuhindioglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)