Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
10 de dezembro de 2014 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
126
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
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Manitoba
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Winnipeg, Manitoba, Canadá, R3Y 1X1
- Recrutamento
- Health Sciences Centre
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Contato:
- Maria Loureiro
- Número de telefone: 204-787-2404
- E-mail: healthtrials@hsc.mb.ca
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
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
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Pain Visual Analogue Scale (PVAS)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ryan J Amadeo, MD, University of Manitoba
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
1 de outubro de 2012
Conclusão Primária (Antecipado)
1 de junho de 2016
Conclusão do estudo (Antecipado)
1 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
8 de outubro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de outubro de 2012
Primeira postagem (Estimativa)
30 de outubro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de dezembro de 2014
Última verificação
1 de dezembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B2012:062
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