Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

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.