Bertolotti's SyndromeNCT06225583
Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
An observational study of Bertolotti's Syndrome and Lower Back Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bertolotti's Syndrome, Lower Back Pain
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 20 Bertolotti's Syndrome patients and 20 lower back pain patients
Who may be able to join
- Lower Back Pain Cohort
- Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
- Age ≥ 18 years
- Bertolotti's Syndrome Cohort
- Positive diagnosis of Bertolotti's Syndrome
- Age ≥ 18 years
- Positive imaging for Bertolotti's Syndrome
- Previous analgesic injection results
Who cannot join
- Lower Back Pain Cohort
- History of spinal deformity, previous spinal surgeries, spinal infections
- Pregnant women
- Bertolotti's Syndrome Cohort
- History of spinal deformity, previous spinal surgeries, spinal infections
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.
- Conditions
- Bertolotti's Syndrome, Lower Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bertolotti's Syndrome | Subjects with Bertolotti's Syndrome. | |
| Non-Bertolotti's Lower Back Pain | Subjects without Bertolotti's Syndrome with lower back pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start17 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bertolotti's SyndromeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Steinmetz, MD, The Cleveland Clinic
- Investigators
- Michael Steinmetz, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225583
- Sponsor's protocol ID
- IRB 22-1310
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
- ClinicalTrials.gov ID
- NCT06225583
- Acronym / sponsor ID
- IRB 22-1310
- Conditions
- Bertolotti's Syndrome, Lower Back Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2024 (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.
The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bertolotti's Syndrome | – | –Subjects with Bertolotti's Syndrome. |
| Non-Bertolotti's Lower Back Pain | – | –Subjects without Bertolotti's Syndrome with lower back pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 Bertolotti's Syndrome patients and 20 lower back pain patients
Key inclusion criteria (8 listed)
- Lower Back Pain Cohort
- Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
- Age ≥ 18 years
- Bertolotti's Syndrome Cohort
- Positive diagnosis of Bertolotti's Syndrome
Key exclusion criteria (6 listed)
- Lower Back Pain Cohort
- History of spinal deformity, previous spinal surgeries, spinal infections
- Pregnant women
- Bertolotti's Syndrome Cohort
- History of spinal deformity, previous spinal surgeries, spinal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.
Time frame: 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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.
Michael Steinmetz, MD principal investigator
The Cleveland Clinic
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 Bertolotti's Syndrome and Lower Back Pain, run by The Cleveland Clinic 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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 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?
This study is still under way. Results are not available in the source record yet.
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?
To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks. (time frame: 2025). 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 8 Apr 2026.