Columbia University Vagelos College of Physicians and Surgeons
New York, 10032, United States
NCT Number: NCT03744260
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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Notify Me18 year and older
All sexes
Observational
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
are:
Exclusion criteria
are:
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.
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.
Time frame: Up to 3 months after radiofrequency ablation procedure
Area will be measured by MRI scan.
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").
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.
Columbia University
Other
The Effect of Medial Branch Radiofrequency Ablation on Functional Spinal Stability and Lumbar Multifidi Muscle Architecture Assessed by Magnetic Resonance Imaging and Ultrasound Imaging
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