Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain

NCT04249453 | Completed

• 1 other identifier: F3300-P
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is strongly associated with opioid consumption among Veterans, and improved clinical management of LBP is likely to reduce reliance on opioid among Veterans. Up to 60% of patients with an acute episode of nonspecific LBP experience either symptom persistence or symptom relapse within one year. This is likely an indication of a failure in addressing the underlying mechanisms of pain or initiation of a new etiology; both may stem from a mismatch between patients and treatments. The overall goal of this research is to develop, validate and implement measures that are relevant to known mechanisms of LBP, which can then be used to holistically gauge the health status of patients' lower backs beyond self-reporting of symptoms. More accurate measurements will help better match of patients with existing treatments or development of more effective new treatments. The specific objective of this study is to generate evidence in support of the feasibility of the investigators' methods for 1) the evaluation of relative contribution of lower back tissues to spinal loads, and 2) the investigation of the resultant spinal loads in Veterans with non-specific LBP. The investigators have developed a powerful set of tools for the comprehensive assessment of spinal loads and lower back mechanical behavior (MB), that will enable the investigators to examine the existence or development of abnormalities in spinal loads and lower back MB in three groups of Veterans with different experiences with non-specific LBP. These groups will include 1) Veterans with chronic, non-specific LBP and high level of disability (n=18), 2) Veterans with chronic, non-specific LBP and low level of disability (n=18), 3) asymptomatic Veterans without a recent history of non-specific LBP (n=18; serving as control group). Successful completion of this feasibility project will pave the way for future studies (merit grant applications) that will verify the role of abnormalities in lower back MB and spinal loads in the clinical presentation of LBP. Such an understanding has the potential to help the affected Veterans with disabling non-specific LBP. Specifically, measures of lower back MB and spinal loads can be used not only to identify Veterans with mechanical abnormalities in their lower back who are likely to experience LBP in the future, but also to guide novel integrated physical and psychological preventative treatments aimed at improved lower back mechanics. Ultimately, the goal and resultant improvement in clinical outcomes of treatment for non-specific LBP is to diminish reliance on opioids for the symptom management of particularly Veterans with chronic LBP.

Conditions

Chronic Low Back Pain

Keywords

Back pain; Lumbar spine; Biomechanics; Spinal loads

Outcome Measures

Primary Outcomes (6)

• Estimates of Spinal load from finite element model

  The maximum spinal load experienced at the L5-S1 level during each activity. This measure is estimated by our finite element model. The input to the model will be measurements of trunk and pelvis motion

  Within a week of data collection for each participant, 12-18 month for all participants

• Reflex delay calculated using measurements of muscle EMG and trunk kinetics

  Latency of reflexive response of trunk muscles to sudden perturbations. This measure will be calculated using a system identification and by relating measured muscle activities (EMG) and trunk kinetics.

  Within a week of data collection for each participant, 12-18 month for all participants

• Intrinsic stiffness calculated using measurements of trunk kinetics and kinematics

  Intrinsic stiffness refers to aspects of lower back mechanical behavior that are quantified during the reflex delay period (i.e., between perturbation onset and reflexive muscle response), and which incorporate both passive and active contributions of lower back tissues.

  Within a week of data collection for each participant, 12-18 month for all participants

• Reflexive force calculated using measurements of muscle EMG and trunk kinetics

  The maximum value of reflexive response of trunk muscles to sudden perturbations. To obtain the maximum reflexive force, the reflexive responses of lower back will be estimated by subtracting the intrinsic response from the measured trunk response (i.e., reaction force from load cell) over a time window between the end of latency period and 150 msec post perturbation.

  Within a week of data collection for each participant, 12-18 month for all participants

• Passive stiffness calculated using measurements of trunk kinetics and kinematics

  Average stiffness of lower back obtained from the stress-relaxation test.

  Within a week of data collection for each participant, 12-18 month for all participants

• Viscoelastic relaxation calculated using measurements of trunk kinetics and kinematics

  The amount of relaxation in passive resistance of lower back during the stress-relaxation test.

  Within a week of data collection for each participant, 12-18 month for all participants

Study Arms (3)

Chronic low back pain with high disability

Veterans with chronic, non-specific LBP and a Roland-Morris Disability Questionnaire (RMDQ) score of \>12 (gender-balanced, n1=18)

Chronic low back pain with low disability

Veterans with chronic, non-specific LBP and a RMDQ score of 12 (gender-balanced, n2=18)

Controls

Asymptomatic veterans with no recent history of LBP (gender-balanced, n3=18)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 54 gender-balanced veterans in the following three groups: 1) with chronic, non-specific LBP and a Roland-Morris Disability Questionnaire (RMDQ) score of \>12 (n=18), 2) with chronic, non-specific LBP and a RMDQ score of =12 (n=18), 3) asymptomatic and no a recent history of non-specific LBP (n=18; serving as control group)

You may qualify if:

• Age between 21 and 70 years old
• Body mass index between 22 and 32

You may not qualify if:

• Any spinal surgery \[e.g., spinal fusion surgery\]
• Any abnormalities in lower extremity joints due to disease or injury that would likely affects lower back mechanics \[e.g., lower limb amputation or peripheral arterial disease\]
• Any safety concern \[e.g., pregnancy\]
• Any medical condition for which we can't determine the impact of the investigators' experimental procedures. \[e.g., we don't know whether our measurement instrument will affect pacemakers.\]
• Can't complete the tolerability tests for sudden perturbation and stress-relaxation (see description given under "Risk versus benefits")\]
• Inability to read or verbally comprehend English
• Unwilling or unable to comply with study protocol
• Retention of legal advice or an open / pending legal case related to LBP

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Kentucky: collaborator

Study Sites (1)

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Babak Bazrgari, PhD

  Lexington VA Medical Center, Lexington, KY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: January 15, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 14, 2022
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)