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治験 NCT07433634（対象：腰痛、Vertebrogenic Pain Syndrome、Basivertebral nerve ablation）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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イェール大学Time to BBVNA Relief 200 RWE
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07433634 は 観察研究 臨床試験 で、腰痛、Vertebrogenic Pain Syndrome、Basivertebral nerve ablation に関するものです。現在は 募集中 で、2024年4月19日 から開始しています。200 名の参加者 の募集が計画されています。この試験は イェール大学 によって主導され、2026年10月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月3日 です。
概要
Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline p...もっと見る
詳細説明
Primary Objective:
• To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.
Secondary Objectives:
- To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.
- To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.
- To evaluate temporal trends in res...
公式タイトル
Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study
疾患名
腰痛Vertebrogenic Pain SyndromeBasivertebral nerve ablationその他の研究識別子
- 2000040858
NCT番号
開始日
2024-04-19
最終更新日
2026-03-03
終了予定日
2026-10
目標参加者数
200
試験の種類
観察研究
状況
募集中
キーワード
Pain relief trajectory
Basivertebral nerve ablation
Vertebrogenic low back pain,
Responder phenotypes
Clinical Outcomes
Radiofrequency Ablation
Basivertebral nerve ablation
Vertebrogenic low back pain,
Responder phenotypes
Clinical Outcomes
Radiofrequency Ablation
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
該当なし | Basivertebral nerve ablation Participants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% ver...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of participants achieving clinical response | Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score | 2 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in PROMIS-7 Global Health Score | 7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health. | 2 years |
Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS) | 2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2. | 2 years |
Incidence of spine-related interventions | Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation. | 2 years |
Patient Global Impression of Change (PGIC) score | Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7. | 2 years |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Diagnosis of chronic axial low back pain with vertebrogenic features
- Scheduled for BVN ablation
- Able to provide informed consent
- Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years
- Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months
- Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation
- Cognitive impairment limiting ability to complete surveys or provide informed consent
- Pregnancy
- Incarceration or current status as a prisoner
イェール大学試験中央連絡先
連絡先: Charles A Odonkor, MD, 203-767-1555, [email protected]
連絡先: Muhammad U Siddique, MD, 203-668-2772, [email protected]
3 1カ国の場所
Connecticut
Yale Spine and Pain Center - Guilford, Guilford, Connecticut, 06437, United States
募集中
Yale Pain Management Center - New Haven, New Haven, Connecticut, 06519, United States
募集中
Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook, Old Saybrook, Connecticut, 06475, United States
募集中