Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

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NeuroTherapia, Inc.

Status

Enrolling

Conditions

Lower Back Pain
Bertolotti's Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT06225583
IRB 22-1310

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Bertolotti's Syndrome
Description:
Subjects with Bertolotti's Syndrome.
Non-Bertolotti's Lower Back Pain
Description:
Subjects without Bertolotti's Syndrome with lower back pain.

Trial contacts and locations

1

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Central trial contact

nya robinson; Claudia Tellman

Data sourced from clinicaltrials.gov

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