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

NCT ID: NCT01717430

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neck Pain Back Pain

Keywords

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Injections, epidural Injections, intra-articular Chronic pain Neck pain Back pain Low back pain Sciatica Sacroiliac joint Corticosteroids Dexamethasone Adrenocorticotropic hormone Adrenal insufficiency Hemoglobin A, glycosylated

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ryan Amadeo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan J Amadeo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ryan J Amadeo, MD

Role: CONTACT

Phone: 204-787-1414

Email: [email protected]

Facility Contacts

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Maria Loureiro

Role: primary

Other Identifiers

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B2012:062

Identifier Type: -

Identifier Source: org_study_id