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Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06225583
Enrollment
40
Registered
2024-01-26
Start date
2024-01-17
Completion date
2026-12-31
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bertolotti's Syndrome, Lower Back Pain

Brief 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. 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.

Interventions

None listed

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.2025

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael Steinmetz, MD

The Cleveland Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026