Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
10 de diciembre de 2014 actualizado por: Dr. Ryan Amadeo, University of Manitoba
Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status
Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used for the treatment of chronic neck, low back, and leg pain. These injections may have several side effects, including suppression of the body's adrenal glands to produce steroids (adrenal suppression) and negative effects on metabolism (weight gain, increased blood pressure, and high blood sugar levels).
The purpose of this study is to determine the time course and predictors of adrenal suppression and the metabolic effects of corticosteroid injections for chronic pain.
The investigators hypothesize normalization of adrenal function to occur within three weeks of injection in most individuals. An increased frequency of injections is predicted to lead to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic individuals.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
Interventional pain procedures using corticosteroid injections (CIs), such as epidural steroid injections (ESIs) and sacroiliac joint injections (SIJIs), may have adverse metabolic and endocrine effects, including suppression of the hypothalamic-pituitary-adrenal axis (HPAA), hypertension, weight gain, and hyperglycemia. Based on sparse data on these adverse effects following repeated, long-term CIs, current guidelines suggest a maximum frequency of four to six injections annually, even though patients may benefit from more frequent treatments.
This prospective cohort study will follow first-time or repeat ESI or SIJI patients receiving injections with 0.5 mL bupivacaine 0.25% and 15 mg dexamethasone sodium phosphate at a maximum frequency of once every six weeks in order to:
- determine the frequency and duration of HPAA suppression;
- determine the incidence and predictors of prolonged (≥ 3 weeks) HPAA suppression;
- determine the baseline incidence and predictors of HPAA suppression in chronic pain patients presenting for their first CI; and
- determine the effect of CIs on body weight, resting blood pressure, and glycemic control over a six-month period.
Tipo de estudio
De observación
Inscripción (Anticipado)
126
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.
Estudio Contacto
- Nombre: Ryan J Amadeo, MD
- Número de teléfono: 204-787-1414
- Correo electrónico: ramadeo@shaw.ca
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3Y 1X1
- Reclutamiento
- Health Sciences Centre
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Contacto:
- Maria Loureiro
- Número de teléfono: 204-787-2404
- Correo electrónico: healthtrials@hsc.mb.ca
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients receiving initial or repeated sacroiliac (SI) joint injections or single- or multi-level epidural injections with corticosteroids as part of their management plan for chronic SI joint, neck, back, or radicular pain.
Descripción
Inclusion Criteria:
- Patients receiving SI joint or epidural corticosteroid injections
- At least 18 years of age
Exclusion Criteria:
- Contraindication to corticosteroid injection (infection; pregnancy; uncontrolled diabetes mellitus [per patient's report]; active congestive heart failure; coagulopathy; medical conditions that prohibit holding anticoagulant or antiplatelet therapy, with the exception of aspirin, for at least two weeks prior to injection; and allergy to iodinated contrast dye, corticosteroids, or amide local anesthetics)
- Known disorder of the hypothalamic-pituitary-adrenal axis
- Corticosteroid injection within 6 weeks of study enrollment
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Corticosteroid injection
Consecutive patients receiving initial or repeated sacroiliac joint or single or multi-level epidural corticosteroid injections as part of their management plan for SI joint, neck, back, or radicular pain.
Injections will be performed using 0.5 mL bupivacaine 0.25% and 15 mg dexamethasone sodium phosphate.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Periodo de tiempo: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
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The high-dose rapid adrenocorticotropic hormone (ACTH) stimulation test will be performed to determine if HPAA suppression is present.
Serum cortisol will be measured by electrochemiluminescence immunoassay immediately prior to and at 30 and 60 min following injection of 250 mcg cosyntropin IV.
A serum cortisol level <550 nmol/L (<20 mcg/dL) at either time point following cosyntropin administration will designate HPAA suppression.
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From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Periodo de tiempo: Baseline
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The high-dose rapid ACTH stimulation test will be performed at Baseline to determine if HPAA suppression is present in patients presenting for corticosteroid injection.
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Baseline
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Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
Periodo de tiempo: From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
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The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.
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From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
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Change in Glycosylated HbA1c (%) from Baseline to 3 months
Periodo de tiempo: Baseline and 3 months
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Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
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Baseline and 3 months
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Change in Glycosylated HbA1c (%) from Baseline to 6 months
Periodo de tiempo: Baseline and 6 months
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Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
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Baseline and 6 months
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Change in Systolic Blood Pressure from Baseline to 3 weeks
Periodo de tiempo: Baseline and 3 weeks
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Baseline and 3 weeks
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Change in Systolic Blood Pressure from Baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks
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Baseline and 6 weeks
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Change in Systolic Blood Pressure from Baseline to 3 months
Periodo de tiempo: Baseline and 3 months
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Baseline and 3 months
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Change in Systolic Blood Pressure from Baseline to 6 months
Periodo de tiempo: Baseline and 6 months
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Baseline and 6 months
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Change in Diastolic Blood Pressure from Baseline to 3 weeks
Periodo de tiempo: Baseline and 3 weeks
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Baseline and 3 weeks
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Change in Diastolic Blood Pressure from Baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks
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Baseline and 6 weeks
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Change in Diastolic Blood Pressure from Baseline to 3 months
Periodo de tiempo: Baseline and 3 months
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Baseline and 3 months
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Change in Diastolic Blood Pressure from Baseline to 6 months
Periodo de tiempo: Baseline and 6 months
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Baseline and 6 months
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Change in Body Weight from Baseline to 3 weeks
Periodo de tiempo: Baseline and 3 weeks
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Percent Change in Body Weight
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Baseline and 3 weeks
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Change in Body Weight from Baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks
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Percent Change in Body Weight
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Baseline and 6 weeks
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Change in Body Weight from Baseline to 3 months
Periodo de tiempo: Baseline and 3 months
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Percent Change in Body Weight
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Baseline and 3 months
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Change in Body Weight from Baseline to 6 months
Periodo de tiempo: Baseline and 6 months
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Percent Change in Body Weight
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Baseline and 6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Visual Analogue Scale (PVAS)
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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11-point scale for average pain intensity over the preceding week.
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Functional Capacity Visual Analogue Scale (FVAS)
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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11-point scale for average functional impairment over the preceding week.
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Oswestry Disability Index (ODI) v2.0 Scores
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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North American Spine Society Patient Satisfaction Index (PSI)
Periodo de tiempo: Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ryan J Amadeo, MD, University of Manitoba
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 2012
Finalización primaria (Anticipado)
1 de junio de 2016
Finalización del estudio (Anticipado)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
8 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
25 de octubre de 2012
Publicado por primera vez (Estimar)
30 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
10 de diciembre de 2014
Última verificación
1 de diciembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2012:062
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. .
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