Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Turkey (Türkiye)
NCT Number: NCT07445477
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.
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Notify Me30 year–80 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
This prospective, randomized, parallel-group comparative study was conducted to evaluate the clinical effectiveness of ultrasound-guided lumbar erector spinae plane block compared with fluoroscopy-guided caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment.
Eligible participants were randomized into two intervention arms. Patients in the erector spinae plane block group received a lumbar 4 level ultrasound-guided injection of local anesthetic administered under sterile conditions. Patients in the caudal epidural steroid injection group received a fluoroscopy-guided caudal epidural injection consisting of corticosteroid and local anesthetic according to institutional protocol.
The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS) for leg pain. Assessments were performed before the procedure, 1 hour after injection, and at 4 and 8 weeks following the intervention.
Secondary clinical evaluations included functional status and walking capacity assessed at predefined follow-up intervals.
The study was approved by the local ethics committee, and written informed consent was obtained from all participants prior to enrollment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
LSS-DST (Lumbar Spinal Stenosis - Diagnostic Support Tool) Scoring System
Exclusion criteria
History of lumbar epidural steroid injection within the last 6 months or history of major trauma
Ultrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions.
Caudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol.
Time frame: Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.
Visual Analog Scale (VAS) for leg pain measured on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Hatice Çetintürk Şahin
Other
A Prospective Comparative Study Evaluating the Effectiveness of Erector Spinae Plane Block Versus Caudal Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis Refractory to Conservative Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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