Sacroiliac Joint Arthritis Causing Low Back PainNCT01719081
Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound
A study testing Sacroiliac Joint Injection in people with Sacroiliac Joint Arthritis Causing Low Back Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sacroiliac Joint Arthritis Causing Low Back Pain
- What is being tested?
- Sacroiliac Joint Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Aug 2013
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
- Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
- Baseline NRS pain score > or = to 4
- Refractory to oral analgesic therapy
Who cannot join
- ongoing litigation issues related to the patient's pain
- pregnancy
- allergy to steroids or local anesthetics
- multiple comorbidities
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection
This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.
Read the detailed description
The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.
- Being tested
- Sacroiliac Joint Injection
- Keywords
- Sacroiliac Joint, Ultrasound, Fluoroscopy, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac Joint InjectionProcedure or surgery
Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided SIJ Injection | Experimental | Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection. Receives: Procedure: Sacroiliac Joint Injection |
| Xray Guided SIJ Injection | Active comparator | Needle placement will be performed under fluoroscopy. Receives: Procedure: Sacroiliac Joint Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of needle placement into SIJ
Measured: Assessed at time of injection
Pain - Numeric Rating Scale Score at 1 month
Measured: One month from time of injection
Secondary outcomes (5)
Improvement of functional ability at 1 month
Oswestry Disability Index completed at 1 month to determine level of disability
Measured: 1 month from time of injection
Patient Satisfaction
Measured: 1 month from time of injection
Average daily consumption of opioids at 1 month
Measured: 1 month from injection
Patient discomfort with procedure
Measured: Measured at time of procedure
Number of needle readjustments
Measured: Measured at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint Arthritis Causing Low Back PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anuj Bhatia, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719081
- Sponsor's protocol ID
- 11-0880-AE
- Status last verified
- Dec 2013
- First submitted
- 29 Oct 2012
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection
- ClinicalTrials.gov ID
- NCT01719081
- Acronym / sponsor ID
- 11-0880-AE
- Keywords
- Sacroiliac Joint, Ultrasound, Fluoroscopy, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Nov 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.
This project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (SIJ). Intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (US) for this procedure. US avoids radiation exposure to the patient and the health care team (HCT) and is less expensive. We aim to compare procedural efficacy related outcomes for SIJ injections performed using these image-guided modalities.
Detailed description
The study is a prospective, randomized trial. Patients with low back pain which is diagnosed secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. Record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. The final position of the needle will be recorded. Pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be followed up at 3 months time in clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided SIJ Injection | Experimental | Procedure: Sacroiliac Joint InjectionNeedle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection. |
| Xray Guided SIJ Injection | Active comparator | Procedure: Sacroiliac Joint InjectionNeedle placement will be performed under fluoroscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms
- Two positive responses to the following maneuver: FABER (flexion abduction and external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)
- Baseline NRS pain score > or = to 4
- Refractory to oral analgesic therapy
Key exclusion criteria (5 listed)
- ongoing litigation issues related to the patient's pain
- pregnancy
- allergy to steroids or local anesthetics
- multiple comorbidities
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacroiliac Joint InjectionMedication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg. | Procedure or surgery | Ultrasound Guided SIJ Injection, Xray Guided SIJ Injection |
Primary outcome
Incidence of needle placement into SIJ
Time frame: Assessed at time of injection
Pain - Numeric Rating Scale Score at 1 month
Time frame: One month from time of injection
5 secondary outcomes
Improvement of functional ability at 1 month
Time frame: 1 month from time of injection
Patient Satisfaction
Time frame: 1 month from time of injection
Average daily consumption of opioids at 1 month
Time frame: 1 month from injection
Patient discomfort with procedure
Time frame: Measured at time of procedure
Number of needle readjustments
Time frame: Measured at time of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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.
Anuj Bhatia, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacroiliac Joint Injection in people with Sacroiliac Joint Arthritis Causing Low Back Pain, run by University Health Network, Toronto 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of needle placement into SIJ (time frame: Assessed at time of injection). The study lists 2 primary outcomes in all. 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 23 Dec 2016.