F-18 Sodium Fluoride PET/CT Guided Versus Ultrasound- Guided Intra-articular Injections in Chronic Low Backache (PET-FACET)
2 de junio de 2026 actualizado 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Chandigarh
-
Chandigarh, Chandigarh, India, 160012
- Post Graduate Institute of Medical Education Research, Chandigarh
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
|
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
From date of intervention to the follow up at 20 weeks
|
|
Change in Low Back Outcome Score (LBOS)
Periodo de tiempo: From date of intervention to follow up at 20 weeks
|
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.
|
From date of intervention to follow up at 20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between baseline SUVmax and improvement in Visual Analog Scale (VAS) score
Periodo de tiempo: 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 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.
|
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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de mayo de 2025
Finalización primaria (Actual)
25 de mayo de 2026
Finalización del estudio (Actual)
25 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INT/IEC/2025/SPL-1127
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .