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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249453
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : December 16, 2022
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease
Chronic Low Back Pain

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Assessment of Lower Back Mechanical Behavior and Spinal Loads in Veterans With Non-specific Low Back Pain: a Feasibility Study
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : December 13, 2022
Actual Study Completion Date : December 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
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)



Primary Outcome Measures :
  1. Estimates of Spinal load from finite element model [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    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

  2. Reflex delay calculated using measurements of muscle EMG and trunk kinetics [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    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.

  3. Intrinsic stiffness calculated using measurements of trunk kinetics and kinematics [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    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.

  4. Reflexive force calculated using measurements of muscle EMG and trunk kinetics [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    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.

  5. Passive stiffness calculated using measurements of trunk kinetics and kinematics [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    Average stiffness of lower back obtained from the stress-relaxation test.

  6. Viscoelastic relaxation calculated using measurements of trunk kinetics and kinematics [ Time Frame: Within a week of data collection for each participant, 12-18 month for all participants ]
    The amount of relaxation in passive resistance of lower back during the stress-relaxation test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249453


Locations
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United States, Kentucky
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
VA Office of Research and Development
University of Kentucky
Investigators
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Principal Investigator: Babak Bazrgari, PhD Lexington VA Medical Center, Lexington, KY
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04249453    
Other Study ID Numbers: F3300-P
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Back pain
Lumbar spine
Biomechanics
Spinal loads
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations