Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis
Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis
Lumbar spinal stenosis is a common degenerative condition that can cause chronic low back and leg pain, especially during walking or standing. Interlaminar epidural steroid injections are widely used to relieve pain and improve function in patients who do not respond adequately to conservative treatments.
These injections are usually performed under fluoroscopic guidance, which allows accurate needle placement but exposes patients and healthcare providers to ionizing radiation. Ultrasound guidance has emerged as an alternative technique that avoids radiation exposure; however, ultrasound alone may not always confirm correct epidural spread of the injected medication.
This prospective, randomized clinical trial aims to compare two commonly used imaging approaches for interlaminar epidural steroid injections in patients with lumbar spinal stenosis: fluoroscopy-guided injection and ultrasound-guided injection with fluoroscopic confirmation (hybrid technique). The study will evaluate patient satisfaction, radiation exposure, procedure time, technical success, pain relief, and functional outcomes.
The results of this study are expected to help identify the most effective and safe imaging guidance method for interlaminar epidural steroid injections in patients with lumbar spinal stenosis.
연구 개요
상태
정황
상세 설명
This prospective, randomized clinical trial will compare two imaging guidance strategies for interlaminar epidural steroid injection in adult patients diagnosed with lumbar spinal stenosis. Eligible participants will be randomly allocated into two groups: a fluoroscopy-guided interlaminar epidural steroid injection group and an ultrasound-guided interlaminar epidural steroid injection group with fluoroscopic confirmation of epidural spread (hybrid technique).
All procedures will be performed at a single tertiary care center by experienced clinicians using standardized institutional protocols. In both groups, the interlaminar epidural space will be accessed using a midline or paramedian approach, and the same corticosteroid formulation and injection volume will be administered to ensure treatment consistency.
Procedural outcomes will include total procedure time, fluoroscopy time, radiation dose parameters recorded directly from the fluoroscopy unit, and technical success defined as correct epidural space access with appropriate contrast spread. Radiation exposure will be assessed using dose metrics provided by the imaging system, allowing comparison between the two guidance techniques.
Patient-reported outcomes will be evaluated using validated pain and functional assessment tools at baseline and during routine follow-up visits according to the study protocol. Patient satisfaction will be assessed following the procedure. Adverse events related to the procedure will be documented and monitored throughout the study period.
By systematically comparing these two imaging guidance approaches under standardized clinical conditions, this study aims to clarify whether ultrasound-guided interlaminar epidural steroid injection with fluoroscopic confirmation can reduce radiation exposure while maintaining procedural efficiency, technical accuracy, and clinical effectiveness comparable to conventional fluoroscopy-guided injection.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pendik
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Istanbul, Pendik, 터키 (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
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연락하다:
- Gamze G Güleç, MD
- 전화번호: +905528671324
- 이메일: gamzegulgulec@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 40 and 75 years
- Diagnosis of lumbar spinal stenosis confirmed by clinical evaluation and magnetic resonance imaging (MRI)
- Presence of neurogenic claudication symptoms for at least 3 months
- Inadequate response to conservative treatment, including medication, physical therapy, or exercise
- Numeric Rating Scale (NRS) pain score ≥ 4 at baseline
- Ability to provide written informed consent
Exclusion Criteria:
- Previous lumbar spine surgery
- Vertebral fracture, spinal malignancy, or history of significant lumbar trauma
- Peripheral vascular claudication or clinically significant peripheral polyneuropathy
- Epidural steroid injection within the past 6 months
- Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip/knee osteoarthritis)
- Pregnancy or breastfeeding
- Coagulation disorders or inability to safely discontinue anticoagulant or antiplatelet therapy according to guideline recommendations
- Known allergy to local anesthetics, corticosteroids, or contrast agents
- Active local or systemic infection
- Body mass index (BMI) > 30 kg/m²
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
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Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
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활성 비교기: Fluoroscopy-guided lumbar interlaminar epidural steroid injection
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.
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Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction
기간: Immediately after the procedure
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Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
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Immediately after the procedure
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Radiation Exposure
기간: During the procedure
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Radiation exposure measured as air kerma (mGy) during the procedure.
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During the procedure
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Procedure Time
기간: During the procedure
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Procedure time defined as the duration from identification of the target interlaminar space using ultrasound or fluoroscopy to completion of the injection.
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During the procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity
기간: Baseline, 1 hour, and 3 weeks after the procedure
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Pain intensity assessed using the Numeric Rating Scale (NRS).
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Baseline, 1 hour, and 3 weeks after the procedure
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Functional Status
기간: Baseline and 3 weeks after the procedure
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Functional status assessed using the Oswestry Disability Index (ODI).
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Baseline and 3 weeks after the procedure
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Technical Success
기간: During the procedure
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Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.
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During the procedure
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Number of Needle Insertions
기간: During the procedure
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Number of needle insertion attempts required to complete the procedure.
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During the procedure
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Fluoroscopy Time
기간: During the procedure
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Total fluoroscopy time automatically recorded by the fluoroscopy unit during the procedure.
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During the procedure
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MU-HYBRID-ILESI-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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