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Clinical Trial Summary

The study is being performed to determine if adding an objective measurement of back function can assess the success of a commonly performed back injection procedure-lumbar medial branch blocks. Researchers also hope to compare whether those who have objective improvements after lumbar medial branch blocks will also have more successful lumbar medial branch radiofrequency ablation.


Clinical Trial Description

The current standard of care to determine the success of lumbar medical branch block(s) (MBB) is highly subjective, even if clinicians were to use validated questionairres. Currently, there are no studies that use a validated objective functional outcome measure to practically and efficiently assess lumbar MBB success prior to radiofrequency ablation (RFA). The addition of a validated objective measure of functional impairment to the current standard of care may help us improve in identifying the patients that will benefit from lumbar RFA. It has the potential to minimize procedures of limited benefit with a significant impact on containing healthcare spending. Additionally, it may further knowledge on how to appropriately select patients without relying on the stringent double block diagnostic technique put forth by the CMS that may exclude patients who could greatly benefit from a lumbar RFA. As the objective measure the study will use a lumber motion monitor (LMM). The LMM weighs less than 5 pounds and fits on with a shoulder harness and belt. The LMM measures motion in all three directions (forward back, side to side, and twisting) just like the spine. The LMM testing may take up to 30 minutes depending on how many tasks can be performed by the participant and how many practice trials are required. The LMM testing includes bending forward and back to upright as fast as possible; comfortably while maintaining a twist position. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03894319
Study type Observational
Source Ohio State University
Contact
Status Withdrawn
Phase
Start date June 6, 2018
Completion date February 19, 2021

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