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NCT Number: NCT06225583

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Bertolotti's Syndrome Back Pain Low Back Pain Lower Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 2025

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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