Neck PainNCT01717430
Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
An observational study of Neck Pain and Back Pain, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Type of treatment
- Injection or infusion
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients receiving SI joint or epidural corticosteroid injections
- At least 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3Y 1X1
Maria Loureiro, 204-787-2404, healthtrials@hsc.mb.ca
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- 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
- Medical subject headings
- Neck Pain, Back Pain, Chronic Pain, Low Back Pain, Sciatica, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
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.
Measured: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
Secondary outcomes (16)
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
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.
Measured: Baseline
Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.
Measured: 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
Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
Measured: Baseline and 3 months
Change in Glycosylated HbA1c (%) from Baseline to 6 months
Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
Measured: Baseline and 6 months
Change in Systolic Blood Pressure from Baseline to 3 weeks
Measured: Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Measured: Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Measured: Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Measured: Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Measured: Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Measured: Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Measured: Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Measured: Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Percent Change in Body Weight
Measured: Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Percent Change in Body Weight
Measured: Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Percent Change in Body Weight
Measured: Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Percent Change in Body Weight
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ryan Amadeo, University of Manitoba
- Investigators
- Ryan J Amadeo, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717430
- Sponsor's protocol ID
- B2012:062
- Status last verified
- Dec 2014
- First submitted
- 8 Oct 2012
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status
- ClinicalTrials.gov ID
- NCT01717430
- Acronym / sponsor ID
- B2012:062
- Keywords
- Injections, epidural, Injections, intra-articular, Chronic pain, Neck pain, Back pain, Low back pain, Sciatica, Sacroiliac joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients receiving SI joint or epidural corticosteroid injections
- At least 18 years of age
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
Time frame: 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.
16 secondary outcomes
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
Time frame: Baseline
Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
Time frame: 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
Time frame: Baseline and 3 months
Change in Glycosylated HbA1c (%) from Baseline to 6 months
Time frame: Baseline and 6 months
Change in Systolic Blood Pressure from Baseline to 3 weeks
Time frame: Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Time frame: Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Time frame: Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Time frame: Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Time frame: Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan J Amadeo, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Back Pain, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan J Amadeo, MD (204-787-1414, ramadeo@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection (time frame: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.