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

10 décembre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

126

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3Y 1X1
        • Recrutement
        • Health Sciences Centre
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 3 weeks
Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Délai: Baseline and 6 weeks
Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Délai: Baseline and 3 months
Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Délai: Baseline and 6 months
Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Délai: Baseline and 3 weeks
Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Délai: Baseline and 6 weeks
Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Délai: Baseline and 3 months
Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Délai: Baseline and 6 months
Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Délai: Baseline and 3 weeks
Percent Change in Body Weight
Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Délai: Baseline and 6 weeks
Percent Change in Body Weight
Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Délai: Baseline and 3 months
Percent Change in Body Weight
Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Délai: Baseline and 6 months
Percent Change in Body Weight
Baseline and 6 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pain Visual Analogue Scale (PVAS)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Manitoba

Les enquêteurs

  • Chercheur principal: Ryan J Amadeo, MD, University of Manitoba

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2012

Achèvement primaire (Anticipé)

1 juin 2016

Achèvement de l'étude (Anticipé)

1 décembre 2016

Dates d'inscription aux études

Première soumission

8 octobre 2012

Première soumission répondant aux critères de contrôle qualité

25 octobre 2012

Première publication (Estimation)

30 octobre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 décembre 2014

Dernière vérification

1 décembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • B2012:062

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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