Spinal Stenosis LumbarNCT07855419
Sarcopenia and Interlaminar Epidural Steroid Injection Outcomes in Lumbar Spinal Stenosis
An observational study of Spinal Stenosis Lumbar and Sarcopenia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Spinal Stenosis Lumbar, Sarcopenia
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, Istanbul, 34899
Konuralp Karbeyaz, +90 216 625 45 45, nurbanuhindioglu@gmail.com
About this study
Official title: 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.
- Conditions
- Spinal Stenosis Lumbar, Sarcopenia
- Keywords
- Sarcopenia, Epidural injection, Spinal stenosis
- Medical subject headings
- Sarcopenia, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 weeks, and 3 months
Secondary outcomes (4)
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.
Measured: Baseline, 3 weeks, and 3 months
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.
Measured: Baseline, 3 weeks, and 3 months
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.
Measured: Baseline, 3 weeks, and 3 months
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.
Measured: Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start2 Oct 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855419
- Sponsor's protocol ID
- 09.2026.878
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sarcopenia and Outcomes of Interlaminar Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07855419
- Acronym / sponsor ID
- 09.2026.878
- Conditions
- Spinal Stenosis Lumbar, Sarcopenia
- Keywords
- Sarcopenia, Epidural injection, Spinal stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Time frame: 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.
4 secondary outcomes
Change in Low Back Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Time frame: Baseline, 3 weeks, and 3 months
Change in Functional Disability Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Time frame: Baseline, 3 weeks, and 3 months
Change in Health-Related Quality of Life Following Interlaminar Epidural Steroid Injection by Sarcopenia Status
Time frame: Baseline, 3 weeks, and 3 months
Correlation Between Erector Spinae Cross-Sectional Area and Leg Pain Outcome
Time frame: Baseline Magnetic Resonance Imaging; leg pain at baseline, 3 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis Lumbar and Sarcopenia, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konuralp Karbeyaz (+90 216 625 45 45, nurbanuhindioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Leg Pain Following Interlaminar Epidural Steroid Injection by Sarcopenia Status (time frame: Baseline, 3 weeks, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.