Use of Lumbar Motion Monitor (LMM) as a Prognostic Tool to Predict Response to Medial Branch Radiofrequency Ablation After Medial Branch Diagnostic Blocks
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in functional performance probability P(n).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in functional performance probability P(n).
时间窗: collected at time points Day 1; Weeks 2,4, and 6; and Months 3,6, and 9
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)).
次要结局
- 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)
研究者
JayeshVallabh
Assistant Professor- Physical Medicine & Rehabilitation
Ohio State University
