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

10. december 2014 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

126

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3Y 1X1
        • Rekruttering
        • Health Sciences Centre
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Visual Analogue Scale (PVAS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Manitoba

Efterforskere

  • Ledende efterforsker: Ryan J Amadeo, MD, University of Manitoba

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Forventet)

1. juni 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

8. oktober 2012

Først indsendt, der opfyldte QC-kriterier

25. oktober 2012

Først opslået (Skøn)

30. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2012:062

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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