An observational study in Back Pain, sponsored by Ohio State University. Withdrawn at 1 site in United States. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Ohio State University · Observational
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
Browse Back Pain studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients at the Ohio State Comprehensive Spine Center scheduled to undergo lumbar medial branch blockade and possible subsequent radiofrequency ablation.
Exclusion Criteria:
Change in functional performance probability P(n).
The Lumbar Motion Monitor (LMM) is an objective, validated, reproducible and accurate tool to rapidly assess the degree of impairment with a sensitivity and specificity of 92% and 97%, respectively. This device provides a functional measure of trunk range of motion, flexion velocity, extension velocity, flexion acceleration, extension acceleration and compares recordings to a normative database. The LMM is able to provide an overall impairment score known as a "functional performance probability(P(n)).
Time frame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
Change in Numeric Rating Scale for Pain
Validated as a measure of pain. Widely used and mandated through the Department of Veterans Affairs as a pain assessment tool.Use of the NRS for MBB and RFA success is the current post procedure assessment standard of care and widely used nationally and within the Ohio State Spine Center clinics.
Time frame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
PROMIS 29
The PROMIS® 29 Profile v. 2.0 contains 29 items from 8 domains-Physical Function, Depression, Anxiety, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity. These PROMIS® Physical Function measures have been validated for the assessment of back pain.
Time frame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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