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

NCT03894319 | Withdrawn

• 1 other identifier: 2018H0197
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Numeric Rating Scale for Pain

  collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9

• PROMIS 29

  collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jayesh Vallabh, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- Physical Medicine & Rehabilitation

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: June 6, 2018
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (1)