Medial Branch Radiofrequency Ablation and Lumbar Multifidi

NCT ID: NCT03744260

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.

Detailed Description

Radiofrequency ablation (RFA) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. The procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. This nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. The investigators are conducting a study to evaluate if RFA has any impact on multifidi size, spinal stability, and overall function. The tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, MRI, physical therapy assessment, and functional questionnaires. The goal of the study is to determine if RFA impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.

Conditions

Spondylosis; Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Patients undergo ultrasound and lumbar MRI

Patients undergo ultrasound, physical therapy exam and MRI before and after the radiofrequency ablation procedure that they are getting as part of their regular care.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Aged over 18 years
• Presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) *Unilateral back pain without radicular symptoms
• Positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side)
• Ability to complete outcome measure forms.

Exclusion Criteria

• Prior spinal surgery
• Prior RFA procedures
• Pregnancy
• Contraindications to MRI
• Presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely
• Presence of neurologic changes
• Active tobacco smoking history
• Presence of active litigation
• Presence of open workers compensation case

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Clark Smith

Associate Professor of Rehabilitation and Regenerative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clark C. Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Vagelos College of Physicians and Surgeons

New York, New York, United States

Countries

United States

Other Identifiers

AAAR1440

Identifier Type: -

Identifier Source: org_study_id