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Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections

10 dicembre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Anticipato)

126

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3Y 1X1
        • Reclutamento
        • Health Sciences Centre
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Lasso di tempo: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
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.
From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Lasso di tempo: Baseline
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.
Baseline
Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
Lasso di tempo: From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.
From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
Change in Glycosylated HbA1c (%) from Baseline to 3 months
Lasso di tempo: Baseline and 3 months
Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
Baseline and 3 months
Change in Glycosylated HbA1c (%) from Baseline to 6 months
Lasso di tempo: Baseline and 6 months
Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
Baseline and 6 months
Change in Systolic Blood Pressure from Baseline to 3 weeks
Lasso di tempo: Baseline and 3 weeks
Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Lasso di tempo: Baseline and 6 weeks
Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Lasso di tempo: Baseline and 3 months
Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Lasso di tempo: Baseline and 6 months
Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Lasso di tempo: Baseline and 3 weeks
Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Lasso di tempo: Baseline and 6 weeks
Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Lasso di tempo: Baseline and 3 months
Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Lasso di tempo: Baseline and 6 months
Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Lasso di tempo: Baseline and 3 weeks
Percent Change in Body Weight
Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Lasso di tempo: Baseline and 6 weeks
Percent Change in Body Weight
Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Lasso di tempo: Baseline and 3 months
Percent Change in Body Weight
Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Lasso di tempo: Baseline and 6 months
Percent Change in Body Weight
Baseline and 6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Visual Analogue Scale (PVAS)
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
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.
Baseline and 3, 6, 12, and 24 weeks
Functional Capacity Visual Analogue Scale (FVAS)
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
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.
Baseline and 3, 6, 12, and 24 weeks
Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
Baseline and 3, 6, 12, and 24 weeks
Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
Baseline and 3, 6, 12, and 24 weeks
Oswestry Disability Index (ODI) v2.0 Scores
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
Baseline and 3, 6, 12, and 24 weeks
North American Spine Society Patient Satisfaction Index (PSI)
Lasso di tempo: Baseline and 3, 6, 12, and 24 weeks
Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
Baseline and 3, 6, 12, and 24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manitoba

Investigatori

  • Investigatore principale: Ryan J Amadeo, MD, University of Manitoba

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2012

Completamento primario (Anticipato)

1 giugno 2016

Completamento dello studio (Anticipato)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

8 ottobre 2012

Primo inviato che soddisfa i criteri di controllo qualità

25 ottobre 2012

Primo Inserito (Stima)

30 ottobre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B2012:062

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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