Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
10 de octubre de 2013 actualizado por: University of Florida
A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized.
Both groups will receive the standard of care, a medial branch block.
The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
Fase
- Fase temprana 1
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
-
-
Florida
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Gainesville, Florida, Estados Unidos, 32607
- UF & Shands Orthopaedics and Sports Medicine Institute
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-
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
45 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Low back pain episode greater than six months in duration
- NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- Previous medial branch block providing >80% pain relief for current painful episode
- Subject must be scheduled to undergo a second medial branch block for their back pain
Exclusion Criteria:
- Litigation
- Those seeking new or increased long-term remuneration
- Leg pain greater than back pain
- Radicular pain or evidence of neurological compromise in the lower limbs
- Those unable to read English and complete the assessment instruments
- Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
- Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
- Significant lower extremity pathology that affects gait
- Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
- Possible pregnancy or other reason that precludes the use of fluoroscopy
- Significant scoliosis
- Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
- Contra-indication to corticosteroid, including known allergies or sensitivities
- History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
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|
Comparador de placebos: Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc normal saline in each joint
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Periodo de tiempo: Hourly for 6 hours post injections
|
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
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Hourly for 6 hours post injections
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric Pain Rating (NPR) Daily diary
Periodo de tiempo: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
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reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
|
Oswestry Disability Index (ODI)
Periodo de tiempo: 6 weeks, 3 months, 6 months, 12 months
|
Patient will complete ODI at the follow-up intervals.
|
6 weeks, 3 months, 6 months, 12 months
|
|
Standard Form 36 (SF-36), General Health Survey
Periodo de tiempo: 6 weeks, 3 months, 6 months, 12 months
|
Patient will complete the SF-36 at the follow-up intervals.
The SF-36 is a self-administered, generic, general health survey consisting of 36 questions.
The questions focus on the functional health and well being of the subject completing the form.
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6 weeks, 3 months, 6 months, 12 months
|
|
Daily Work History Log
Periodo de tiempo: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
|
Patient will keep a Work History Log during participation.
The Log should indicate the daily work activities of the subject.
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reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
|
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Daily Analgesic Use Log
Periodo de tiempo: reviewed at 6 weeks, 3 months, 6 months, 12 months
|
Patient will keep a Daily Analgesic Use Log during participation.
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reviewed at 6 weeks, 3 months, 6 months, 12 months
|
|
Ancillary Treatment Log
Periodo de tiempo: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
Patient will keep an Ancillary Treatment Log during participation.
This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.
|
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: D. J. Kennedy, M.D., UF Department of Orthopaedics and Rehabilitation
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
1 de octubre de 2010
Finalización primaria (Actual)
1 de septiembre de 2012
Finalización del estudio (Actual)
1 de septiembre de 2012
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2011
Publicado por primera vez (Estimar)
27 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de octubre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
10 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 319-2010
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
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