Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
10. desember 2014 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
126
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3Y 1X1
- Rekruttering
- Health Sciences Centre
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Ta kontakt med:
- Maria Loureiro
- Telefonnummer: 204-787-2404
- E-post: healthtrials@hsc.mb.ca
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain Visual Analogue Scale (PVAS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ryan J Amadeo, MD, University of Manitoba
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Forventet)
1. juni 2016
Studiet fullført (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
8. oktober 2012
Først innsendt som oppfylte QC-kriteriene
25. oktober 2012
Først lagt ut (Anslag)
30. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2012:062
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .