Clinical trial NCT03744260: Medial Branch Radiofrequency Ablation and Lumbar Multifidi
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylosis
Osteoarthritis
Keywords: Lower back pain
Radiofrequency ablation
Spine
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with back pain caused by osteoarthritis or degeneration of the facet joint.

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.

Eligibility 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

Primary outcomes:
measure: Percentage Change in Volume of multifidus muscle on MRI
timeFrame: Up to 3 months after radiofrequency ablation procedure
measure: Percentage Change in Cross Sectional Area of Multifidi
timeFrame: Up to 3 months after radiofrequency ablation procedure
Secondary outcomes:
measure: Score on Numeric Pain Rating Scale (NPRS)
timeFrame: Up to 3 months after radiofrequency ablation procedure
measure: Percentage Score on the Modified Oswestry Disability Index
timeFrame: Up to 3 months after radiofrequency ablation procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Vagelos College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Clark C. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: