Back PainUSGSLBBNCT02750436
A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
A study testing Ultrasound guided and Fluoroscopy guided in people with Back Pain, run by Montreal General Hospital at 1 site in Canada.
Trial summary
Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Ultrasound guided and Fluoroscopy guided
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2016to 30 Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.
Who cannot join
- Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.
- Conditions
- Back Pain
- Being tested
- Ultrasound guided, Fluoroscopy guided
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidedDevice
Also called Ultrasound guided sacral lateral branch block
This group will be treated using an ultrasound imaging device
Fluoroscopy guidedDevice
Also called Fluoroscopically guided sacral lateral branch block
This group will be treated using a fluoroscopy imaging device
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided | Experimental | Ultrasound guided sacral lateral branch block Receives: Device: Ultrasound guided |
| Fluoroscopy guided | Active comparator | Fluoroscopically guided sacral lateral branch block Receives: Device: Fluoroscopy guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance time
Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups.
Measured: Duration of procedure (less than 20 minutes)
Secondary outcomes (1)
Change in pain numerical rating score from baseline
The extent of anesthesia provided by the blocks will be assessed by probing structures known to be innervated by the lateral branches and L5 posterior root. Two pain measurements will be undertaken, before and 20 minutes after the injections. Pain reports will be quantified by using a numerical rating score.
Measured: Baseline and 20 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start25 Apr 2016
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick Finlayson, Montreal General Hospital
- Investigators
- Roderick J Finlayson, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750436
- Sponsor's protocol ID
- 15-544MUHC
- Acronym
- USGSLBB
- Status last verified
- Mar 2017
- First submitted
- 17 Apr 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
- ClinicalTrials.gov ID
- NCT02750436
- Acronym / sponsor ID
- USGSLBB / 15-544MUHC
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 25 Apr 2016 (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.
Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided | Experimental | Device: Ultrasound guidedUltrasound guided sacral lateral branch block |
| Fluoroscopy guided | Active comparator | Device: Fluoroscopy guidedFluoroscopically guided sacral lateral branch block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.
Key exclusion criteria (1 listed)
- Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.
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 |
|---|---|---|
| Ultrasound guidedAlso: Ultrasound guided sacral lateral branch blockThis group will be treated using an ultrasound imaging device | Device | Ultrasound guided |
| Fluoroscopy guidedAlso: Fluoroscopically guided sacral lateral branch blockThis group will be treated using a fluoroscopy imaging device | Device | Fluoroscopy guided |
Primary outcome
Performance time
Time frame: Duration of procedure (less than 20 minutes)
Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups.
1 secondary outcome
Change in pain numerical rating score from baseline
Time frame: Baseline and 20 minutes after 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 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Roderick J Finlayson, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided and Fluoroscopy guided in people with Back Pain, run by Montreal General Hospital 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 1 inclusion and 1 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 27 Mar 2017. 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?
Performance time (time frame: Duration of procedure (less than 20 minutes)). 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 27 Mar 2017.