Identifying Bertolotti Syndrome using new movement measurements
Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
This study is testing a new way to measure movement and pain in people with Bertolotti Syndrome compared to those with regular lower back pain to see if it helps identify the condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06225583 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on lumbar rotations, velocity, and accelerations from patients diagnosed with Bertolotti Syndrome and those with non-Bertolotti lower back pain. Using a novel dynamic visual analog scale (VAS) device, the study will measure pain scores during range-of-motion tasks. The goal is to analyze the differences in kinematics and pain experiences between the two patient groups, which could lead to more precise identification of Bertolotti Syndrome.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Bertolotti's Syndrome or lower back pain due to sacroiliac pain or lumbosacral facet arthritis.
Not a fit: Patients with a history of spinal deformity, previous spinal surgeries, spinal infections, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing Bertolotti Syndrome, leading to better-targeted treatments for patients.
How similar studies have performed: While this approach is innovative, it builds on existing methodologies for assessing movement and pain, but specific prior successes in this exact context are not documented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Michael Steinmetz, MD — The Cleveland Clinic
- Study coordinator: nya robinson
- Email: robinsn8@ccf.org
- Phone: 216-445-1741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.