Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

February 8, 2024 updated by: Michael Steinmetz, MD, The Cleveland Clinic
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bertolotti's Syndrome
Subjects with Bertolotti's Syndrome.
Non-Bertolotti's Lower Back Pain
Subjects without Bertolotti's Syndrome with lower back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Michael Steinmetz, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 22-1310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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