Medial Branch Radiofrequency Ablation and Lumbar Multifidi

NCT03744260 | Completed

• 1 other identifier: AAAR1440
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylosis; Osteoarthritis

Keywords

Lower back pain; Radiofrequency ablation; Spine

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Volume of multifidus muscle on MRI

  Analysis will include volumetric measurements of the multifidi as well as volumetric assessments of the muscle with fat subtracted.

  Up to 3 months after radiofrequency ablation procedure

• Percentage Change in Cross Sectional Area of Multifidi

  Area will be measured by MRI scan.

  Up to 3 months after radiofrequency ablation procedure

Secondary Outcomes (2)

• Score on Numeric Pain Rating Scale (NPRS)

  Up to 3 months after radiofrequency ablation procedure

• Percentage Score on the Modified Oswestry Disability Index

  Up to 3 months after radiofrequency ablation procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with back pain caused by osteoarthritis or degeneration of the facet joint.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Vagelos College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Spondylosis; Osteoarthritis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clark C. Smith, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)