Use of Lumbar Motion Monitor to Predict Response to Radiofrequency Ablation After Medial Branch Diagnostic Blocks

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03894319
• Other study ID #: 2018H0197
• Status: Withdrawn
• Start date: June 6, 2018
• Est. completion date: February 19, 2021

Study information

• Verified date: April 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
Secondary	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.	collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
Secondary	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.	collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9