Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

NCT06225583 | Active Not Recruiting

• 1 other identifier: IRB 22-1310
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain; Bertolotti's Syndrome

Outcome Measures

Primary Outcomes (1)

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

  2025

Study Arms (2)

Bertolotti's Syndrome

Subjects with Bertolotti's Syndrome.

Non-Bertolotti's Lower Back Pain

Subjects without Bertolotti's Syndrome with lower back pain.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 Bertolotti's Syndrome patients and 20 lower back pain patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Steinmetz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Neurosurgery

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)