Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

NCT ID: NCT06225583

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-17

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bertolotti's Syndrome Lower Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bertolotti's Syndrome

Subjects with Bertolotti's Syndrome.

No interventions assigned to this group

Non-Bertolotti's Lower Back Pain

Subjects without Bertolotti's Syndrome with lower back pain.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael Steinmetz, MD

Chairman, Department of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Steinmetz, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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nya robinson

Role: CONTACT

216-445-1741

Claudia Tellman

Role: CONTACT

216-444-3026

Facility Contacts

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Michael Steinmetz

Role: primary

Other Identifiers

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IRB 22-1310

Identifier Type: -

Identifier Source: org_study_id

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