Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

Last updated: March 12, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lower Back Pain

Treatment

N/A

Clinical Study ID

NCT06225583
IRB 22-1310
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 40
Study Start date:
January 17, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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