Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain
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ClinicalTrials.gov Identifier: NCT04249453 |
Recruitment Status :
Completed
First Posted : January 31, 2020
Last Update Posted : December 16, 2022
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Condition or disease |
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Chronic Low Back Pain |

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 |
Group/Cohort |
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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)
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Chronic low back pain with low disability
Veterans with chronic, non-specific LBP and a RMDQ score of 12 (gender-balanced, n2=18)
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Controls
Asymptomatic veterans with no recent history of LBP (gender-balanced, n3=18)
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- 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
- 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.
- 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.
- 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.
- 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.
- 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.

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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 |
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

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
United States, Kentucky | |
Lexington VA Medical Center, Lexington, KY | |
Lexington, Kentucky, United States, 40502 |
Principal Investigator: | Babak Bazrgari, PhD | Lexington VA Medical Center, Lexington, KY |
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 |
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 |
Back pain Lumbar spine Biomechanics Spinal loads |
Back Pain Low Back Pain Pain Neurologic Manifestations |