Association Between Sarcopenia and Outcomes of Interlaminar Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis: A Prospective Observational Study
| Registry | NCT07855419 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 70 (Estimated) |
| Sponsor | Marmara University (Other) |
| Conditions | Spinal Stenosis Lumbar, Sarcopenia |
| Dates | start 2026-10-02, primary completion 2027-03-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-10-02, last updated 2026-10-07 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Spinal Stenosis Lumbar All trials for Sarcopenia
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Marmara University Pendik Training and Research Hospital | Istanbul, Istanbul | Turkey (Türkiye) | Recruiting |