F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache (PET-FACET)
2026年6月2日 更新者：Rajender Kumar、Post Graduate Institute of Medical Education and Research, Chandigarh
F-18 Sodium Fluoride PET/CT Guided Pain Palliation in Chronic Low Backache : Comparing the Efficacy of Ultrasound - Guided Vs PET/CT Guided Intra-articular Injections of Corticosteroid and Local Anesthetic.
The goal of this open-label randomized controlled trial explored the efficacy of ultrasound guided versus F-18 Sodium Fluoride PET/CT guided local anesthetic and steroid injections in managing chronic low back pain caused by lumbar facet and sacroiliac joint arthritis.. The main questions it aims to answer are:
- To Compare the reduction in pain intensity between PET/CT guided and Ultrasound Guided facet joint injections using the Visual Analog Scale (VAS) at predefined follow up intervals.
- To compare functional improvement and disability outcomes between two study arms using Oswestry Disability Index (ODI) and Low Back Outcome Score (LBOS).
- To compare association of PET/CT associated parameters with post intervention clinical response associated parameters.
Patients fulfilling the inclusion criteria will be randomly allocated to one of two groups. Randomization will be conducted using a computer-generated random sequence, ensuring a 1:1 allocation ratio between the two treatment groups
- Group A: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid plus local anesthetic injection.
- Group B: Patients receiving Ultrasound-guided corticosteroid plus local anesthetic injection
調査の概要
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chandigarh
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Chandigarh、Chandigarh、インド、160012
- Post Graduate Institute of Medical Education Research, Chandigarh
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Patients with a chronic nociceptive low backache attending the orthopaedic department who do not get adequate relief with conservative treatments for more than three months will be recruited in the study.
- Patients who are ready to give informed consent
Exclusion Criteria:
- Pregnant and lactating females
- Patients with active infection and febrile illness
- Patients with acute spine trauma
- Spinal pathologies requiring surgical interventions such as significant spinal stenosis , spondylolisthesis or disc herniation.
- Patients with corticosteroid injection within six weeks before the study
- Patients who refused to give written informed consent
- MRI showing the neuropathic cause or nerve root compression
- Patients with deranged coagulation profile
- Systemic conditions affecting joints (eg ankylosing spondylitis , rheumatoid arthritis)
- Uncontrolled diabetes
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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アクティブコンパレータ：F-18 Sodium Fluoride Guided intra-articular Injection
Patients in this group will PET/CT guided intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid
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• A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under F-18 sodium fluoride PET/CT guidance, with doses equally divided for multiple joints, if required
A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under ultrasound(USG) guidance, with doses equally divided for multiple joints, if required
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アクティブコンパレータ：Ultrasound Guided Pain Palliation
Patients in this group will undergo ultrasound-guided (USG) intra articular block of the facet joint or sacroiliac joint using local anesthetic and corticosteroid
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• A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under F-18 sodium fluoride PET/CT guidance, with doses equally divided for multiple joints, if required
A combination of steroids (80 mg methylprednisolone acetate) and 0.5% bupivacaine will be injected into the intra-articular and periarticular regions of the targeted LFJ(lumbar facet Joint) or SIJ(sacroiliac Joint) under ultrasound(USG) guidance, with doses equally divided for multiple joints, if required
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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 |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
時間枠：From date of intervention to follow up at 20 weeks.
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Change in pain intensity from baseline to follow-up as measured using the Visual Analog Scale (VAS).
The VAS is a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate less pain.
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From date of intervention to follow up at 20 weeks.
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Change in Oswestry Disability Index (ODI)
時間枠：From date of intervention to the follow up at 20 weeks
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Change in disability from baseline to follow-up as measured using the Oswestry Disability Index (ODI).
The ODI is scored from 0% to 100%, with higher scores indicating greater disability and poorer functional status.
Lower scores indicate improvement in disability.
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From date of intervention to the follow up at 20 weeks
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Change in Low Back Outcome Score (LBOS)
時間枠：From date of intervention to follow up at 20 weeks
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Change in functional outcome from baseline to follow-up as measured using the Low Back Outcome Score (LBOS).
The LBOS ranges from 0 to 75 points, with higher scores indicating better functional outcome and lower levels of disability.
Higher scores indicate improvement in functional status.
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From date of intervention to follow up at 20 weeks
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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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Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
時間枠：From baseline F-18 Sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
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Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in pain severity assessed using the Visual Analog Scale (VAS; 0-10 points).
Improvement will be calculated as the difference between baseline and follow-up VAS scores.
Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate.
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From baseline F-18 Sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
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Correlation between baseline SUVmax and improvement in Oswestry Disability Index (ODI) score
時間枠：From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in disability assessed using the Oswestry Disability Index (ODI; 0-100%).
Improvement will be calculated as the difference between baseline and follow-up ODI scores.
Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate.
|
From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
|
Correlation between baseline SUVmax and improvement in Low Back Outcome Score (LBOS)
時間枠：From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
Correlation between baseline maximum standardized uptake value (SUVmax) measured on PET/CT and change in functional outcome assessed using the Low Back Outcome Score (LBOS; 0-75 points).
Improvement will be calculated as the difference between baseline and follow-up LBOS scores.
Correlation analysis will be performed using Pearson's or Spearman's correlation coefficient, as appropriate.
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From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年5月14日
一次修了 (実際)
2026年5月25日
研究の完了 (実際)
2026年5月25日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- INT/IEC/2025/SPL-1127
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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