Medial Branch Radiofrequency Ablation and Lumbar Multifidi

The Effect of Medial Branch Radiofrequency Ablation on Functional Spinal Stability and Lumbar Multifidi Muscle Architecture Assessed by Magnetic Resonance Imaging and Ultrasound Imaging

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Spondylosis
• Intervention / Treatment: Diagnostic test: Patients undergo ultrasound and lumbar MRI

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Vagelos College of Physicians and Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with back pain caused by osteoarthritis or degeneration of the facet joint.

Description

Inclusion criteria are:

• 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 are:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Volume of multifidus muscle on MRI	Analysis will include volumetric measurements of the multifidi as well as volumetric assessments of the muscle with fat subtracted.	Up to 3 months after radiofrequency ablation procedure
Percentage Change in Cross Sectional Area of Multifidi	Area will be measured by MRI scan.	Up to 3 months after radiofrequency ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Numeric Pain Rating Scale (NPRS)	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Respondents are asked to select a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	Up to 3 months after radiofrequency ablation procedure
Percentage Score on the Modified Oswestry Disability Index	This is a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. It examines perceived level of disability in 10 everyday activities of daily living, which each statement scored from 0 (no disability) to 5 (worst pain). An aggregate score (percentage) is then calculated, with 0% indicating no disability to 100%, indicating crippled or bed-bound.	Up to 3 months after radiofrequency ablation procedure

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Clark C. Smith, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; Spine; Lower back pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: AAAR1440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No