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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Pendik
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Istanbul、Pendik、トルコ（Türkiye）、34899
- Marmara University Pendik Training and Research Hospital
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コンタクト：
- Gamze G Güleç, MD
- 電話番号：+905528671324
- メール：gamzegulgulec@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Satisfaction
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- MU-HYBRID-ILESI-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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