Lumbar Spine SpondylosisMBBNCT04453449
The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks
An observational study of Lumbar Spine Spondylosis and Anxiety Generalized, run by Henry Ford Health System at 1 site in United States.
Trial summary
This prospective observational study aims to investigate the effect of midazolam sedation on the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with lumbar spondylosis without myelopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Spondylosis, Anxiety Generalized
- What is being tested?
- Midazolam
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 15 Oct 2021
- 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: Adult patients diagnosed with Lumbar Spondylosis without Myelopathy at either of five study locations (HFMC - Ford Rd, HFMC Main, HFMC West Bloomfield, HFMC Pierson, HFMC - Jackson) from June 1st, 2020 - June 1st, 2021.
Who may be able to join
- Adult patients at least 18 years of age
- History of axial low back pain for at least 3 months
- Indication for bilateral lumbar medial branch block (L3, L4, L5 medial branch nerves)
- Diagnosis of Lumbar Spondylosis without Myelopathy >4/10 pain on a 0-10 numerical rating scale (NRS)
Who cannot join
- Low back pain with radiculopathy symptoms (this is a diagnosis of sciatica and treatment is not with lumbar medial branch block)
- Uncontrolled major depression or other mental health issues causing instability
- Pregnant or lactating women
- <18 years old
- History of adverse reaction to either midazolam, lidocaine, or bupivacaine
- Focal neurological deficits, cognitive impairments, or memory issues
Show all 12Show fewer
- Non-English speaking
- Hearing impaired that are unable to understand verbal instructions
- Active Infection
- On Anticoagulation or Antiplatelet Therapy
- History of Clotting Disorder
- Previous Lumbar Medial Branch Block and/or Lumbar Radiofrequency Ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Investigating the Effect of Midazolam Sedation on Diagnostic Lumbar Medial Branch Blocks
This prospective observational study aims to investigate the effect of midazolam sedation on the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with lumbar spondylosis without myelopathy.
Read the detailed description
This prospective observational study aims to investigate the effects of midazolam sedation on the diagnostic validity of lumbar medial branch blocks in patients diagnosed with lumbar spondylosis without myelopathy. Patients typically receive two subsequent diagnostic blocks prior RFTC, to ensure that the correct location has been targeted. When patients achieve at least 80% pain relief after both diagnostic blocks, this is considered a positive result and they can proceed to receive RFTC. If patients have positive diagnostic blocks but their RFTC is not successful, this is considered a false positive diagnostic result. This study will determine 1) if a higher number of sedated patients proceed to radiofrequency thermocoagulation (RFTC) than non-sedated patients, and 2) if there are a higher number of false positive results in sedated patients. The hypothesis is that the use of midazolam sedation will increase the number of patients who perceive to have pain relief from their diagnostic block results, resulting in more patients proceeding to RFTC, and that there will be a higher number of false positive results in sedated patients. The primary outcome measure is the number of sedated versus non-sedated patients that have positive block results. A positive result will be calculated by having at least one NRS score that is at least 80% lower than their baseline NRS score in the 8 hours following lumbar MBB. The secondary outcome will be the number of false positive blocks in sedated versus non-sedated patients. After patients achieve 80% relief after each of the two diagnostic lumbar medial branch blocks and proceeds with lumbar RFTC, we will then collect NRS scores 24 hours after both diagnostic Lumbar MBB, and 4 weeks and at 8 weeks after the lumbar RFTC. If a patient has not received at least 50% reduction from their baseline NRS score by 8 weeks, this will be considered a false positive. A 7-point Patient Global Impression of Change (PGIC) score 8 hours after each Lumbar MBB will also be collected, and at 4 weeks and 8 weeks after the lumbar RFTC, and any adverse effects patients experience. In addition, Oswestry Disability Index (ODI) will be collected at 4 and 8 weeks after lumbar RFTC. The results of this study will help guide the use of sedation when performing diagnostic blocks on patients with lumbar spondylosis, in order to reduce the number of false positive blocks.
- Conditions
- Lumbar Spine Spondylosis, Anxiety Generalized
- Being tested
- Midazolam
- Keywords
- midazolam, sedation, diagnostic lumbar medial branch block, radiofrequency thermocoagulation
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called sedation
Midazolam given as a sedative during diagnostic lumbar medial branch block
| Study group | Role | What they receive |
|---|---|---|
| No sedation | Patients who will undergo the diagnostic lumbar medial branch blocks without sedation (control group). | |
| Sedation | Patients who will undergo the diagnostic lumbar medial branch blocks with midazolam sedation (treatment group). Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive blocks
The number of positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.
Measured: 8 hours post diagnostic block
Secondary outcomes (1)
Number of false positive blocks
The number of false positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief in the two diagnostic blocks, and then less than 80% pain relief following the subsequent radiofrequency thermocoagulation treatment) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.
Measured: 2.5-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start25 Jun 2020
- Primary completion1 Sep 2021
- Study completion15 Oct 2021
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 Lumbar Spine SpondylosisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Nowak, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453449
- Sponsor's protocol ID
- 14010
- Acronym
- MBB
- Status last verified
- Mar 2022
- First submitted
- 27 Jun 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel N, Nowak K, Vaidyanathan A, Milad H, Adlaka K, Rubino C, Vasquez ET, Nerusu L, Rahavard B, Fayed M, Forrest P, Money S, Dwivedi S, Zador L, Haddad R, Khaja D, Sibai N, Aiyer R. The Effect of Sedation on Diagnostic Lumbar Medial Branch Blocks for Facetogenic Low Back Pain: An Observational Study. Pain Physician. 2024 May;27(4):E407-E418.
PubMed 38805536
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Investigating the Effect of Midazolam Sedation on Diagnostic Lumbar Medial Branch Blocks
- ClinicalTrials.gov ID
- NCT04453449
- Acronym / sponsor ID
- MBB / 14010
- Conditions
- Lumbar Spine Spondylosis, Anxiety Generalized
- Keywords
- midazolam, sedation, diagnostic lumbar medial branch block, radiofrequency thermocoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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 prospective observational study aims to investigate the effect of midazolam sedation on the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with lumbar spondylosis without myelopathy.
Detailed description
This prospective observational study aims to investigate the effects of midazolam sedation on the diagnostic validity of lumbar medial branch blocks in patients diagnosed with lumbar spondylosis without myelopathy. Patients typically receive two subsequent diagnostic blocks prior RFTC, to ensure that the correct location has been targeted. When patients achieve at least 80% pain relief after both diagnostic blocks, this is considered a positive result and they can proceed to receive RFTC. If patients have positive diagnostic blocks but their RFTC is not successful, this is considered a false positive diagnostic result. This study will determine 1) if a higher number of sedated patients proceed to radiofrequency thermocoagulation (RFTC) than non-sedated patients, and 2) if there are a higher number of false positive results in sedated patients. The hypothesis is that the use of midazolam sedation will increase the number of patients who perceive to have pain relief from their diagnostic block results, resulting in more patients proceeding to RFTC, and that there will be a higher number of false positive results in sedated patients. The primary outcome measure is the number of sedated versus non-sedated patients that have positive block results. A positive result will be calculated by having at least one NRS score that is at least 80% lower than their baseline NRS score in the 8 hours following lumbar MBB. The secondary outcome will be the number of false positive blocks in sedated versus non-sedated patients. After patients achieve 80% relief after each of the two diagnostic lumbar medial branch blocks and proceeds with lumbar RFTC, we will then collect NRS scores 24 hours after both diagnostic Lumbar MBB, and 4 weeks and at 8 weeks after the lumbar RFTC. If a patient has not received at least 50% reduction from their baseline NRS score by 8 weeks, this will be considered a false positive. A 7-point Patient Global Impression of Change (PGIC) score 8 hours after each Lumbar MBB will also be collected, and at 4 weeks and 8 weeks after the lumbar RFTC, and any adverse effects patients experience. In addition, Oswestry Disability Index (ODI) will be collected at 4 and 8 weeks after lumbar RFTC. The results of this study will help guide the use of sedation when performing diagnostic blocks on patients with lumbar spondylosis, in order to reduce the number of false positive blocks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No sedation | – | –Patients who will undergo the diagnostic lumbar medial branch blocks without sedation (control group). |
| Sedation | – | Drug: MidazolamPatients who will undergo the diagnostic lumbar medial branch blocks with midazolam sedation (treatment group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Lumbar Spondylosis without Myelopathy at either of five study locations (HFMC - Ford Rd, HFMC Main, HFMC West Bloomfield, HFMC Pierson, HFMC - Jackson) from June 1st, 2020 - June 1st, 2021.
Key inclusion criteria (4 listed)
- Adult patients at least 18 years of age
- History of axial low back pain for at least 3 months
- Indication for bilateral lumbar medial branch block (L3, L4, L5 medial branch nerves)
- Diagnosis of Lumbar Spondylosis without Myelopathy >4/10 pain on a 0-10 numerical rating scale (NRS)
Key exclusion criteria (12 listed)
- Low back pain with radiculopathy symptoms (this is a diagnosis of sciatica and treatment is not with lumbar medial branch block)
- Uncontrolled major depression or other mental health issues causing instability
- Pregnant or lactating women
- <18 years old
- History of adverse reaction to either midazolam, lidocaine, or bupivacaine
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 |
|---|---|---|
| MidazolamAlso: sedationMidazolam given as a sedative during diagnostic lumbar medial branch block | Drug | Sedation |
Primary outcome
Number of positive blocks
Time frame: 8 hours post diagnostic block
The number of positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.
1 secondary outcome
Number of false positive blocks
Time frame: 2.5-3 months
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 7 Mar 2022.
- Derived from this study: PubMed 38805536Patel N, Nowak K, Vaidyanathan A, Milad H, Adlaka K, Rubino C, Vasquez ET, Nerusu L, Rahavard B, Fayed M, Forrest P, Money S, Dwivedi S, Zador L, Haddad R, Khaja D, Sibai N, Aiyer R. The Effect of Sedation on Diagnostic Lumbar Medial Branch Blocks for Facetogenic Low Back Pain: An Observational Study. Pain Physician. 2024 May;27(4):E407-E418.
Related trials for Lumbar Spine Spondylosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Not yet recruiting
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Lumbar Spondylosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
Lumbar Spondylosis, Fusion of Spine
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lumbar Spine Spondylosis and Anxiety Generalized, run by Henry Ford Health System 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 4 inclusion and 12 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 7 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?
Number of positive blocks (time frame: 8 hours post diagnostic block). 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 NCT04453449, 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 7 Mar 2022.