F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache (PET-FACET)
2 de junho de 2026 atualizado por: 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
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Chandigarh
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Chandigarh, Chandigarh, Índia, 160012
- Post Graduate Institute of Medical Education Research, Chandigarh
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
|
• 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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Comparador Ativo: 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
|
• 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
Prazo: From date of intervention to follow up at 20 weeks.
|
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.
|
From date of intervention to follow up at 20 weeks.
|
|
Change in Oswestry Disability Index (ODI)
Prazo: From date of intervention to the follow up at 20 weeks
|
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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
Prazo: 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
|
|
Correlation between baseline SUVmax and improvement in Oswestry Disability Index (ODI) score
Prazo: 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)
Prazo: 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.
|
From baseline F-18 sodium fluoride PET/CT to follow up PET/CT and clinical assessment at 20 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de maio de 2025
Conclusão Primária (Real)
25 de maio de 2026
Conclusão do estudo (Real)
25 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
27 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- INT/IEC/2025/SPL-1127
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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