Low Back PainNCT02862964
Accuro Versus Traditional Landmark Palpation Technique to Determine Accurate Spinal Level for Procedures
An observational study of Low Back Pain, run by University of Virginia at 1 site in United States.
Trial summary
Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- identify L4/L5
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 Jun 2017
- 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 undergoing any interventional pain procedure requiring the presence of an anesthesia provider under fluoroscopy at the UVA Pain Management Clinic
Who may be able to join
- An anesthesia provider under fluoroscopy at the UVA Pain Management Clinic
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.
The investigators aim to assess the benefit of using the Accuro versus traditional landmark palpation technique to determine accurate spinal level for procedures. Patients who undergo interventional pain procedure per standard care under fluoroscopy and require the presence of an anesthesia provider at the UVA Pain Management Clinic will be approached for enrollment.
Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace and mark this point with two dots. Participants will then be taken into the fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. The anesthesiology attending provider in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy. It will then be recorded how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.
Read the detailed description
Patients who are undergoing any interventional pain procedure under fluoroscopy at the UVA Pain Management Clinic will be approached for consent.
- Each participant will sit up on the edge of the bed in the pre-procedural area of fluoroscopy.
- For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots.
- The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not.
- The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure.
- The participant will not be exposed to any additional Fluro/ radiation time for this study
- It will then be recorded by the anesthesia provider, how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.
- Conditions
- Low Back Pain
- Being tested
- identify L4/L5
- Keywords
- back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identify L4/L5Other
- For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots.
- The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not.
- The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure
| Study group | Role | What they receive |
|---|---|---|
| identify L4-5 | Level marked as L4-5 using Accuro and palpation Receives: Other: identify L4/L5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy in identifying the L4-L5 interspace using palpation versus ultrasound imaging (3D).
whether there is a correlation between the landmark traditional technique versus US imaging. Fluoroscopy will serve a s the control (gold standard)
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tiouririne, MD, University of Virginia
- Investigators
- Mohamed Tiouririne, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862964
- Sponsor's protocol ID
- 18684
- Status last verified
- Mar 2022
- First submitted
- 3 May 2016
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
PubMed 21572316Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
PubMed 20696564Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
PubMed 11421838Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
PubMed 14656785Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.
PubMed 21422997
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuro Versus Traditional Landmark Palpation Technique to Determine Accurate Spinal Level for Procedures
- ClinicalTrials.gov ID
- NCT02862964
- Acronym / sponsor ID
- 18684
- Conditions
- Low Back Pain
- Keywords
- back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Aug 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.
Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.
The investigators aim to assess the benefit of using the Accuro versus traditional landmark palpation technique to determine accurate spinal level for procedures. Patients who undergo interventional pain procedure per standard care under fluoroscopy and require the presence of an anesthesia provider at the UVA Pain Management Clinic will be approached for enrollment.
Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace and mark this point with two dots. Participants will then be taken into the fluoroscopy suite for their scheduled procedure. Since the skin marks will not show up on fluoroscopy, and metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. The anesthesiology attending provider in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy. It will then be recorded how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.
Detailed description
Patients who are undergoing any interventional pain procedure under fluoroscopy at the UVA Pain Management Clinic will be approached for consent.
- Each participant will sit up on the edge of the bed in the pre-procedural area of fluoroscopy.
- For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots.
- The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not.
- The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure.
- The participant will not be exposed to any additional Fluro/ radiation time for this study
- It will then be recorded by the anesthesia provider, how many spaces off the palpation and Accuro techniques are from the intended L4/L5 level.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| identify L4-5 | – | Other: identify L4/L5Level marked as L4-5 using Accuro and palpation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing any interventional pain procedure requiring the presence of an anesthesia provider under fluoroscopy at the UVA Pain Management Clinic
Key inclusion criteria (1 listed)
- An anesthesia provider under fluoroscopy at the UVA Pain Management Clinic
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| identify L4/L5* For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots. * The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not. * The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure | Other | identify L4-5 |
Primary outcome
Accuracy in identifying the L4-L5 interspace using palpation versus ultrasound imaging (3D).
Time frame: day one
whether there is a correlation between the landmark traditional technique versus US imaging. Fluoroscopy will serve a s the control (gold standard)
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 10 Mar 2022.
- Background: PubMed 21572316Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
- Background: PubMed 20696564Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.
- Background: PubMed 11421838Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
- Background: PubMed 14656785Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
- Background: PubMed 21422997Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.
- 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.
Mohamed Tiouririne, MD principal investigator
University of Virginia
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 Low Back Pain, run by University of Virginia at 1 site in United States.
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 10 Mar 2022. 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 United States. 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?
Accuracy in identifying the L4-L5 interspace using palpation versus ultrasound imaging (3D). (time frame: day one). 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 NCT02862964, which also lists 5 linked publications.
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 10 Mar 2022.