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

10. Dezember 2014 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

126

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3Y 1X1
        • Rekrutierung
        • Health Sciences Centre
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 3 weeks
Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Zeitfenster: Baseline and 6 weeks
Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Zeitfenster: Baseline and 3 months
Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Zeitfenster: Baseline and 6 months
Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Zeitfenster: Baseline and 3 weeks
Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Zeitfenster: Baseline and 6 weeks
Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Zeitfenster: Baseline and 3 months
Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Zeitfenster: Baseline and 6 months
Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Zeitfenster: Baseline and 3 weeks
Percent Change in Body Weight
Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Zeitfenster: Baseline and 6 weeks
Percent Change in Body Weight
Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Zeitfenster: Baseline and 3 months
Percent Change in Body Weight
Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Zeitfenster: Baseline and 6 months
Percent Change in Body Weight
Baseline and 6 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain Visual Analogue Scale (PVAS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Manitoba

Ermittler

  • Hauptermittler: Ryan J Amadeo, MD, University of Manitoba

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2012

Primärer Abschluss (Voraussichtlich)

1. Juni 2016

Studienabschluss (Voraussichtlich)

1. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

8. Oktober 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Oktober 2012

Zuerst gepostet (Schätzen)

30. Oktober 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Dezember 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Dezember 2014

Zuletzt verifiziert

1. Dezember 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B2012:062

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