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Completed

NCT Number: NCT03744260

Medial Branch Radiofrequency Ablation and Lumbar Multifidi

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Vagelos College of Physicians and Surgeons

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients undergo ultrasound and lumbar MRI

Diagnostic Test

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.

Primary outcomes

  1. Percentage Change in Volume of multifidus muscle on MRI

    Time frame: 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.

  2. Percentage Change in Cross Sectional Area of Multifidi

    Time frame: Up to 3 months after radiofrequency ablation procedure

    Area will be measured by MRI scan.

Secondary outcomes

  1. Score on Numeric Pain Rating Scale (NPRS)

    Time frame: 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").

  2. Percentage Score on the Modified Oswestry Disability Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2018
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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