Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis

NCT07855419 — Recruiting, 70 participants, Marmara University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Association Between Sarcopenia and Outcomes of Interlaminar Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis: A Prospective Observational Study

RegistryNCT07855419
StatusRecruiting
Study typeObservational
Enrollment70 (Estimated)
SponsorMarmara University (Other)
ConditionsSpinal Stenosis Lumbar, Sarcopenia
Datesstart 2026-10-02, primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-10-02, last updated 2026-10-07
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Spinal Stenosis Lumbar All trials for Sarcopenia

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Patients with SarcopeniaPatients 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 SarcopeniaPatients 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.

+Outcome measures

Primary outcomes

  • Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status [Baseline, 3 weeks, and 3 months]: 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.

Secondary outcomes

  • Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status [Baseline, 3 weeks, and 3 months]: 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.
  • Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status [Baseline, 3 weeks, and 3 months]: 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.
  • Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status [Baseline, 3 weeks, and 3 months]: 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.
  • Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome [Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months]: 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.

+Eligibility

Sex: All, ages: 50 Years to 75 Years

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

+Locations (1)

FacilityCityCountryStatus
Marmara University Pendik Training and Research HospitalIstanbul, IstanbulTurkey (Türkiye)Recruiting