Back PainNCT00909272
Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks
An observational study of Back Pain, run by McMaster University at 1 site in Canada.
Trial summary
Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Lumbar medial branch block and Ultrasound landmarks
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Dec 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care pain clinic
Who may be able to join
- Low back and/or leg pain due to possible lumbar facet joint disease
Who cannot join
- patient with BMI>35
- coagulopathy
- allergy to local anesthetic and ultrasound gel
- patient unable to fill out post procedure pain diary
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences-General Location
Hamilton, Ontario, L8N 3Z5
About this study
Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?
Read the detailed description
The diagnostic lumbar medial branch block for low back and radiating to lower extremity due to lumbar facet joint pain has been traditionally done under fluoroscopic guidance. Some recent studies have shown that the diagnostic lumbar medial branch may alternatively be done under ultrasound guidance. This proposed technique has many advantages, avoid radiation exposure and decrease waiting period for patients to have a pain procedure for low back pain. The time taken, patients' satisfaction score, pain score, the distance the needle tip placed under ultrasound and the ideal position visualized under fluoroscopy will be measured. This study will be done in 2 parts. The first part will determine landmarks for ultrasound. It will involve using 5 cadavers. The second part of the study will involve 25 patients. The needles will be placed initially with ultrasound and then will be verified with C-arm fluoroscopy. Certain criteria will be used to determine its feasibility, for example, less than 20 minutes, less than 5 mm.
- Conditions
- Back Pain
- Being tested
- Lumbar medial branch block, Ultrasound landmarks
- Keywords
- ultrasound, diagnostic, lumbar, median branch, block, Lumbar facet joint pain
- Medical subject headings
- Back Pain, Disease, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar medial branch blockProcedure or surgery
The ultrasound probe will be placed perpendicular to skin along the midline of lumbar spinous process on longitudinal view first to count the lumbar level. The midpoint of each lumbar level will be marked on the longitudinal view and then will be rotated ninety degrees counter clockwise to axial view to locate the facet joint and the transverse process of lumbar spine. A #22 gauge 10cm long Quincke spinal needle will be inserted to the target area using in plane approach on the axial view. Then the probe will be rotated ninety degrees clockwise to longitudinal view to ensure needle tip is placed on the cephalad aspect of the transverse process. It will then be immediately confirmed by C-arm fluoroscopy on oblique view.
Ultrasound landmarksProcedure or surgery
The target point is the superior medial aspect of transverse process of lumbar spine from L3 to S1. A #22 gauge 10cm long Quincke spinal needle will be use for needle placement. Needle placement will be visualized with ultrasound. Practice on cadavers with 3 different operators and see if results are reproducible. Verify with fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| US-guided lumbar medial branch block | Patients who have low back pain and/or leg pain due to possible lumbar facet joint disease . Receives: Procedure: Lumbar medial branch block | |
| Cadavers for Ultrasound landmarks | Cadavers donated to the Department of Anatomy in McMaster University will be used to determine the landmarks for ultrasound. Receives: Procedure: Ultrasound landmarks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform a diagnostic lumbar medial branch block using ultrasound guidance, decide if it's practical to perform it, whether patients can tolerate it, can it be performed in a timely manner and the # of needle adjustments required to get target points.
Measured: At time of procedure
Secondary outcomes (1)
Does this procedure correlate with other known procedures, by the distance between the needle tip placed under the ultrasound and the superior medial aspect of transverse process of lumbar spine L3 to S1 visualized under C-arm fluoroscopy.
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 posted27 May 2009 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: One of the investigators has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Joseph Park, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909272
- Sponsor's protocol ID
- 09-039-D
- Status last verified
- Jun 2026
- First submitted
- 22 May 2009
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Shim JK, Moon JC, Yoon KB, Kim WO, Yoon DM. Ultrasound-guided lumbar medial-branch block: a clinical study with fluoroscopy control. Reg Anesth Pain Med. 2006 Sep-Oct;31(5):451-4. doi: 10.1016/j.rapm.2006.06.246.
PubMed 16952818
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Diagnostic Lumbar Medial Branch Blocks
- ClinicalTrials.gov ID
- NCT00909272
- Acronym / sponsor ID
- 09-039-D
- Conditions
- Back Pain
- Keywords
- ultrasound, diagnostic, lumbar, median branch, block, Lumbar facet joint pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: One of the investigators has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 May 2009 (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.
Can an ultrasound machine be used to perform a diagnostic lumbar medial branch block?
Detailed description
The diagnostic lumbar medial branch block for low back and radiating to lower extremity due to lumbar facet joint pain has been traditionally done under fluoroscopic guidance. Some recent studies have shown that the diagnostic lumbar medial branch may alternatively be done under ultrasound guidance. This proposed technique has many advantages, avoid radiation exposure and decrease waiting period for patients to have a pain procedure for low back pain. The time taken, patients' satisfaction score, pain score, the distance the needle tip placed under ultrasound and the ideal position visualized under fluoroscopy will be measured. This study will be done in 2 parts. The first part will determine landmarks for ultrasound. It will involve using 5 cadavers. The second part of the study will involve 25 patients. The needles will be placed initially with ultrasound and then will be verified with C-arm fluoroscopy. Certain criteria will be used to determine its feasibility, for example, less than 20 minutes, less than 5 mm.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided lumbar medial branch block | – | Procedure: Lumbar medial branch blockPatients who have low back pain and/or leg pain due to possible lumbar facet joint disease . |
| Cadavers for Ultrasound landmarks | – | Procedure: Ultrasound landmarksCadavers donated to the Department of Anatomy in McMaster University will be used to determine the landmarks for ultrasound. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care pain clinic
Key inclusion criteria (1 listed)
- Low back and/or leg pain due to possible lumbar facet joint disease
Key exclusion criteria (4 listed)
- patient with BMI>35
- coagulopathy
- allergy to local anesthetic and ultrasound gel
- patient unable to fill out post procedure pain diary
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 |
|---|---|---|
| Lumbar medial branch blockThe ultrasound probe will be placed perpendicular to skin along the midline of lumbar spinous process on longitudinal view first to count the lumbar level. The midpoint of each lumbar level will be marked on the longitudinal view and then will be rotated ninety degrees counter clockwise to axial view to locate the facet joint and the transverse process of lumbar spine. A #22 gauge 10cm long Quincke spinal needle will be inserted to the target area using in plane approach on the axial view. Then the probe will be rotated ninety degrees clockwise to longitudinal view to ensure needle tip is placed on the cephalad aspect of the transverse process. It will then be immediately confirmed by C-arm fluoroscopy on oblique view. | Procedure or surgery | US-guided lumbar medial branch block |
| Ultrasound landmarksThe target point is the superior medial aspect of transverse process of lumbar spine from L3 to S1. A #22 gauge 10cm long Quincke spinal needle will be use for needle placement. Needle placement will be visualized with ultrasound. Practice on cadavers with 3 different operators and see if results are reproducible. Verify with fluoroscopy. | Procedure or surgery | Cadavers for Ultrasound landmarks |
Primary outcome
Perform a diagnostic lumbar medial branch block using ultrasound guidance, decide if it's practical to perform it, whether patients can tolerate it, can it be performed in a timely manner and the # of needle adjustments required to get target points.
Time frame: At time of procedure
1 secondary outcome
Does this procedure correlate with other known procedures, by the distance between the needle tip placed under the ultrasound and the superior medial aspect of transverse process of lumbar spine L3 to S1 visualized under C-arm fluoroscopy.
Time frame: At time of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 16952818Shim JK, Moon JC, Yoon KB, Kim WO, Yoon DM. Ultrasound-guided lumbar medial-branch block: a clinical study with fluoroscopy control. Reg Anesth Pain Med. 2006 Sep-Oct;31(5):451-4. doi: 10.1016/j.rapm.2006.06.246.
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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.
Joseph Park, MD principal investigator
Hamilton Health Sciences Corporation
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 Back Pain, run by McMaster University 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 4 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: withdrawn, as of the sponsor's last update on 12 Jun 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Perform a diagnostic lumbar medial branch block using ultrasound guidance, decide if it's practical to perform it, whether patients can tolerate it, can it be performed in a timely manner and the # of needle adjustments required to get target points. (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909272, which also lists 1 linked publication.
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 Jun 2026.