Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain
Chronic Low Back Pain · Lumbar Facet Syndrome
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 75 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 40 Estimado
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Acerca de la investigación
This prospective, longitudinal observational study evaluates functional recovery, pain intensity, and lumbar mobility after a fluoroscopy-guided lumbar facet joint block in patients with chronic lumbar facet syndrome. Forty patients receiving standard-of-care injections (ropivacaine 0.2% and methylprednisolone) will be observed. Outcomes are measured at baseline and 30 days post-intervention. The primary outcome is the change in Oswestry Disability Index (ODI). Secondary outcomes include changes in the Numeric Rating Scale (NRS) and the modified Schober test.
Leer la descripción completa
Chronic low back pain due to facet joint arthropathy is a common cause of disability.
Fluoroscopy-guided facet joint blocks are widely used in standard practice, but evidence quantifying objective functional and biomechanical recovery beyond pain reduction is limited.
This single-center, prospective, observational, longitudinal study aims to objectively quantify functional recovery. Forty patients aged 18-75 years with clinically and radiologically confirmed lumbar facet syndrome will be observed. The intervention (unilateral fluoroscopy-guided injection of ropivacaine 0.2% \[0.5-1 mL\] and methylprednisolone into the affected facet joint) is performed strictly as part of routine clinical care, independent of study inclusion.
Assessments occur at baseline (T0) and 30 days post-injection (T1). The primary outcome is the change in Oswestry Disability Index (ODI) score. Secondary outcomes are changes in Numeric Rating Scale (NRS) pain scores and the modified Schober test (cm). Adverse events and procedural safety are recorded. The study aims to provide preliminary effect estimates to inform future controlled trials.
¿Quién podría participar?
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Inclusion Criteria:
- Age 18-75 years
- Clinical and radiological diagnosis of lumbar facet syndrome
- Low back pain duration \>3 months
- Baseline NRS pain score ≥4/10
- Signed informed consent for the procedure and study participation
- Cognitive capacity to independently complete the Oswestry Disability Index
Exclusion Criteria:
- Radicular pain or confirmed disc herniation with neural compression
- Coagulopathy or use of anticoagulants not discontinued appropriately
- Active systemic or local infection
- Known allergy to local anaesthetics or corticosteroids
- Pregnancy or lactation
- Previous lumbar spine surgery at the same level
- Inability to comply with follow-up schedule
Población del estudio
Adults aged 18-75 years with chronic low back pain (\>3 months) due to lumbar facet syndrome confirmed by clinical examination and imaging, presenting to the Algology outpatient clinic.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Facet Block
Single group receiving standard-of-care fluoroscopy-guided lumbar facet joint injection of ropivacaine 0.2% (0.5-1 mL) and methylprednisolone into the affected facet joint(s).
Procedure: Fluoroscopy-guided lumbar facet block
Fluoroscopy-guided lumbar facet block PROCEDURE
Under fluoroscopic guidance, a 20G Quincke needle is placed into the target lumbar facet joint or onto the adjacent medial branch. An arthrogram is performed with 0.3 to 0.5 mL of non-ionic contrast to confirm correct dispersion and exclude vascular/intrathecal uptake. Subsequently, 0.5 to 1 mL of a mixture containing ropivacaine 0.2% and methylprednisolone is injected per level. Performed on an outpatient basis under standard monitoring.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Oswestry Disability Index (ODI)
Plazo: Baseline (pre-injection) and 30 days post-injection
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures functional disability in daily activities (0% = no disability, 100% = severe disability). The primary outcome is the change in ODI score from baseline to 30 days. A reduction of ≥10 points is considered clinically significant.
Medidas secundarias
Change in Numeric Rating Scale (NRS) pain score
Plazo: Baseline, immediately post-procedure, and 30 days post-injection
Pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). A clinically significant reduction is defined as at least a 50% decrease from the baseline score.
Change in modified Schober test (lumbar flexion mobility)
Plazo: Baseline and 30 days post-injection
The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range.
Incidence of adverse events
Plazo: Immediately after procedure up to 30 days post-injection
Record of any adverse events including pain at injection site, transient exacerbation of pain, allergic reaction, inadvertent dural puncture, spinal haematoma, or nerve root injury.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Centro Médico Nacional 20 de Noviembre, ISSSTEMexico City, Mexico City, MexicoEstado desconocido
Equipo y fechas
- Patrocinador principal
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
- Inicio del estudio
- 2026-12 Estimado
- Finalización primaria
- 2027-03 Estimado
- Finalización del estudio
- 2027-06 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026