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Medial Branch Radiofrequency Ablation and Lumbar Multifidi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744260
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Clark Smith, 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.

Condition or disease Intervention/treatment
Spondylosis Osteoarthritis 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.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with back pain caused by osteoarthritis or degeneration of the facet joint.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744260


Contacts
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Contact: Clark C. Smith, MD 212-305-3535 cs3028@cumc.columbia.edu

Locations
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United States, New York
Columbia University Vagelos College of Physicians and Surgeons Recruiting
New York, New York, United States, 10032
Contact: Will Douglas, MD    212-305-3535    wid9036@nyp.org   
Principal Investigator: Clark C Smith, MD         
Sub-Investigator: Christopher Visco, MD         
Sub-Investigator: Evan K Johnson, PhD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Clark C. Smith, MD Columbia University

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Responsible Party: Clark Smith, Associate Professor of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03744260    
Other Study ID Numbers: AAAR1440
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clark Smith, Columbia University:
Lower back pain
Radiofrequency ablation
Spine
Additional relevant MeSH terms:
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Spondylosis
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases