Medial Branch Radiofrequency Ablation and Lumbar Multifidi

Completed

• Conditions: Spondylosis; Osteoarthritis

• Registration Number: NCT03744260
• Lead Sponsor: Columbia University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Score on Numeric Pain Rating Scale (NPRS)	Up to 3 months after radiofrequency ablation procedure	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").
Percentage Score on the Modified Oswestry Disability Index	Up to 3 months after radiofrequency ablation procedure	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.

Trial Locations

Locations (1)

Columbia University Vagelos College of Physicians and Surgeons; 🇺🇸 New York, New York, United States