Erector Spinae Plane vs Caudal Epidural Steroid in Lumbar Spinal Stenosis Resistant to Conservati… (NCT07445477) | Clinical Trial Compass
CompletedNot Applicable
Erector Spinae Plane vs Caudal Epidural Steroid in Lumbar Spinal Stenosis Resistant to Conservative Therapy
Turkey (Türkiye)30 participantsStarted 2024-10-10
Plain-language summary
Lumbar spinal stenosis is a common cause of neurogenic claudication and functional limitation in older adults. Epidural steroid injections are frequently used in patients who do not respond to conservative treatments. The erector spinae plane block has recently emerged as a potential alternative interventional technique for pain control in lumbar spine disorders.
This prospective comparative study will evaluate and compare the effectiveness of erector spinae plane block and caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment. Clinical outcomes including pain intensity, functional status, and walking capacity will be assessed at predefined follow-up intervals.
The study aims to determine whether erector spinae plane block provides comparable or superior clinical benefit compared with caudal epidural steroid injection in this patient population.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria
* Age between 30 and 80 years
* Patients with chronic low back pain (lasting longer than 6 months)
* Diagnosis of lumbar spinal stenosis (LSS) confirmed by imaging modalities (CT/MRI) and clinical evaluation
* LSS Diagnostic Support Tool Assessment (LSS-DST) score greater than 7
* Patients who did not benefit from previous conservative treatments
* Presence of a signed written informed consent form indicating willingness to participate in the study
LSS-DST (Lumbar Spinal Stenosis - Diagnostic Support Tool) Scoring System
* Age 60-70 years: +1 point
* Age over 70 years: +2 points
* Absence of Diabetes Mellitus: +1 point
* Positive claudication: +3 points
* Symptoms aggravated by standing: +2 points
* Symptoms relieved by forward flexion: +3 points
* Symptoms induced by forward flexion: -1 point
* Symptoms induced by lumbar extension: +1 point
* Ankle-brachial index ≥ 0.9: +3 points
* Abnormal Achilles tendon reflex: +1 point
* Positive straight leg raise test: -2 points
Exclusion Criteria:
History of lumbar epidural steroid injection within the last 6 months or history of major trauma
* Known allergy to the study medications (lidocaine hydrochloride, dexamethasone 21-phosphate) or to contrast agents
* Presence of unstable chronic medical conditions (e.g., diabetes mellitus, hypertension, chronic obstructive pulmonary disease, heart failure)
* Advanced joint limitations preventing mobilization (e.g., hip or knee osteoarthritis)
* Hi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS) for Leg Pain
Timeframe: Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.