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NCT06225583 Clinical Trial

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

Lower Back Pain Clinical Trial

Official title:
Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06225583
Other study ID # IRB 22-1310
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 17, 2024
Est. completion date December 2026

Study information
Verified date February 2024
Source The Cleveland Clinic
Contact nya robinson
Phone 216-445-1741
Email robinsn8@ccf.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks. 2025
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