Clinical trial NCT03894319: Use of Lumbar Motion Monitor to Predict Response to Radiofrequency Ablation After Medial Branch Diagnostic Blocks
Official title: Use of Lumbar Motion Monitor (LMM) as a Prognostic Tool to Predict Response to Medial Branch Radiofrequency Ablation After Medial Branch Diagnostic Blocks
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Back Pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients at the Ohio State Comprehensive Spine Center scheduled to undergo lumbar medial branch blockade and possible subsequent radiofrequency ablation.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Male or female, 20 years of age to 70 years of age
* Capable and willing to consent
* Participants literate in English language
* Patients with predominately bilateral axial pain and clinical suspicion of lumbar facet pain.
* Patients who have completed conservative care: physical therapy (PT)

Exclusion Criteria:

* History of drug abuse/ dependency
* History of prior lumbar medial branch block or medial branch radiofrequency ablation
* Changes to analgesic regimen in the last 30 days
* Allergy to lidocaine or bupivacaine local anesthetic
* Illiteracy (English)
* Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
* Predominately radicular pain.
* Patient reported limb pain greater than axial low back pain
* Previous lumbar spine surgery
* Any condition that the principle investigator may disqualify the patient
* Pregnancy

Primary outcomes:
measure: Change in functional performance probability P(n).
timeFrame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
Secondary outcomes:
measure: Change in Numeric Rating Scale for Pain
timeFrame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
measure: PROMIS 29
timeFrame: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jayesh Vallabh, MD
role: PRINCIPAL_INVESTIGATOR
References: