Low Back PainNCT02897973
The Impact of Unilateral Lower Limb Amputation on Spinal Loads
An observational study of Low Back Pain, run by University of Kentucky.
Trial summary
The prevalence of low back pain among persons with unilateral lower limb amputation is significantly higher than the rate experienced by the general public. Chronic pain, including low back pain, limits functional independence and negatively impacts quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Activity of daily living
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This project involves secondary analyses of existing data and so will not include a subject recruitment process. Kinematics data collected at Walter Reed National Military Medical Center will be used for estimation of internal muscle forces and the resultant spinal loads and the probability of spinal tissue damage during several basic activities of daily living using a computational model of the lower back. Following an initial assessment, the investigators estimate the following available sample sizes for each activity of daily living: (transfemoral-TFA, transtibial-TTA, and Controls-CTL ) 1) level ground walking at four different speeds (nTFA= 57, nTTA= 53, nCTL= 32), 2) sitting-to-standing and standing-to-sitting (nTFA= 29, nTTA= 20, nCTL= 15), and 3) stair ascending and descending tasks (nTFA= 18, nTTA= 20, nCTL= 15).
Who may be able to join
- For individuals with amputation
- unilateral amputation resulting from traumatic injuries (with no upper-extremity amputations)
- evaluation took place at least 6 months post-injury
- no assistive device use (e.g., canes, walkers, crutches)
- For controls:
- able-bodied individuals without amputation
- to be matched with group with ampuation on the basis of anthropometric measure
Who cannot join
- For individuals with amputation:
- musculoskeletal impairments in the contralateral limb
- neurologic disorder or traumatic brain injury that would affect gait and movement
- pain levels greater than 3 out of 10 on a visual analog scale
- a history of spinal pathologies/LBP prior to injury.
- For controls
- a history of spinal pathologies/LBP
About this study
Official title: Spinal Loads During Activities of Daily Living: Influences of Unilateral Lower-limb Amputation
The prevalence of low back pain among persons with unilateral lower limb amputation is significantly higher than the rate experienced by the general public. Chronic pain, including low back pain, limits functional independence and negatively impacts quality of life. As such, this project will investigate the role of a biomechanical casual pathway in the development of low back pain; to do this, the investigators will explore the relationship between the adopted neuromuscular patterns post-amputation to perform activities of daily living and the risk of developing spinal tissue damage.
Read the detailed description
Despite the higher prevalence of low back pain (LBP) among persons with unilateral lower limb amputation (ULLA) compared to able-bodied individuals, relatively little is known about the fundamental mechanisms underlying this condition. This research represents a first step toward investigating lower back biomechanics using advanced computational modeling techniques to inform the future design of effective interventions for LBP. Specifically, the impact of trunk neuromuscular patterns adopted by persons with ULLA while performing activities of daily living on spinal loads and the risk of spinal tissue damage will be investigated. This will be achieved via secondary biomechanical analyses of a large set of high-quality kinematics data obtained from individuals with and without ULLA performing the following tasks: 1) walking at self-selected and controlled speeds, 2) sit-to-stand and stand-to-sit, and 3) stairs-up and stairs-down. The central hypothesis is that, compared to able-bodied individuals, trunk movement strategies adopted by persons with ULLA to cope with physical demands of common daily activities are associated with a complex pattern of internal muscle forces that result in larger loads on the spine and a higher probability for spinal tissue damage. Investigators' dataset draws from the Biomechanics Laboratory at Walter Reed National Military Medical Center (WRNMMC) which has unprecedented access to a large population of service members with ULLA. Using this unique database, investigators will implement their novel finite element modeling approach to estimate the internal muscle forces (i.e., adopted neuromuscular patterns) needed to perform daily physical activities on the basis of satisfying equilibrium and stability across the entire lumbar spine. Completion of this project will enable the investigators to determine differences in muscle recruitment, as well as the resultant effects on spinal loads and the risk of spinal tissue damage, between persons with and without ULLA. Hence, this pilot project is expected to establish the initial groundwork for future research involving the design of highly specific interventions aimed at trunk neuromuscular behaviors during post-amputation rehabilitation to lessen adverse effects on lower back biomechanics and the potential for LBP.
- Conditions
- Low Back Pain
- Being tested
- Activity of daily living
- Keywords
- Spinal loads, Trunk muscle force, Computational modeling, Unilateral lower limb amputation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity of daily livingOther
walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending
| Study group | Role | What they receive |
|---|---|---|
| Transtibial lower limb amputation | unilateral amputation below knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement. Receives: Other: Activity of daily living | |
| Transfemoral lower limb amputation | unilateral amputation above knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement. Receives: Other: Activity of daily living | |
| Controls | Able-bodied individuals without amputation Receives: Other: Activity of daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum value of summation of predicted forces in all trunk muscles
All outcome measures are obtained from computational simulation of data collected in previous studies.
Measured: At least 6 months post-injury
Maximum spinal load at the lowest level of lumbar spine
All outcome measures are obtained from computational simulation of data collected in previous studies.
Measured: At least 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Babak Bazrgari, PhD, University of Kentucky
- Investigators
- Babak Bazrgari, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897973
- Sponsor's protocol ID
- R03HD086512-01A1
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Loads During Activities of Daily Living: Influences of Unilateral Lower-limb Amputation
- ClinicalTrials.gov ID
- NCT02897973
- Acronym / sponsor ID
- R03HD086512-01A1
- Conditions
- Low Back Pain
- Keywords
- Spinal loads, Trunk muscle force, Computational modeling, Unilateral lower limb amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- Sep 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of low back pain among persons with unilateral lower limb amputation is significantly higher than the rate experienced by the general public. Chronic pain, including low back pain, limits functional independence and negatively impacts quality of life. As such, this project will investigate the role of a biomechanical casual pathway in the development of low back pain; to do this, the investigators will explore the relationship between the adopted neuromuscular patterns post-amputation to perform activities of daily living and the risk of developing spinal tissue damage.
Detailed description
Despite the higher prevalence of low back pain (LBP) among persons with unilateral lower limb amputation (ULLA) compared to able-bodied individuals, relatively little is known about the fundamental mechanisms underlying this condition. This research represents a first step toward investigating lower back biomechanics using advanced computational modeling techniques to inform the future design of effective interventions for LBP. Specifically, the impact of trunk neuromuscular patterns adopted by persons with ULLA while performing activities of daily living on spinal loads and the risk of spinal tissue damage will be investigated. This will be achieved via secondary biomechanical analyses of a large set of high-quality kinematics data obtained from individuals with and without ULLA performing the following tasks: 1) walking at self-selected and controlled speeds, 2) sit-to-stand and stand-to-sit, and 3) stairs-up and stairs-down. The central hypothesis is that, compared to able-bodied individuals, trunk movement strategies adopted by persons with ULLA to cope with physical demands of common daily activities are associated with a complex pattern of internal muscle forces that result in larger loads on the spine and a higher probability for spinal tissue damage. Investigators' dataset draws from the Biomechanics Laboratory at Walter Reed National Military Medical Center (WRNMMC) which has unprecedented access to a large population of service members with ULLA. Using this unique database, investigators will implement their novel finite element modeling approach to estimate the internal muscle forces (i.e., adopted neuromuscular patterns) needed to perform daily physical activities on the basis of satisfying equilibrium and stability across the entire lumbar spine. Completion of this project will enable the investigators to determine differences in muscle recruitment, as well as the resultant effects on spinal loads and the risk of spinal tissue damage, between persons with and without ULLA. Hence, this pilot project is expected to establish the initial groundwork for future research involving the design of highly specific interventions aimed at trunk neuromuscular behaviors during post-amputation rehabilitation to lessen adverse effects on lower back biomechanics and the potential for LBP.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transtibial lower limb amputation | – | Other: Activity of daily livingunilateral amputation below knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement. |
| Transfemoral lower limb amputation | – | Other: Activity of daily livingunilateral amputation above knee resulting from traumatic injuries (with no upper-extremity amputations), evaluation took place at least 6 months post-injury, no assistive device use (e.g., canes, walkers, crutches), no other documented injuries, such as musculoskeletal impairments in the contralateral limb, neurologic disorder or traumatic brain injury that would affect gait and movement. |
| Controls | – | Other: Activity of daily livingAble-bodied individuals without amputation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This project involves secondary analyses of existing data and so will not include a subject recruitment process. Kinematics data collected at Walter Reed National Military Medical Center will be used for estimation of internal muscle forces and the resultant spinal loads and the probability of spinal tissue damage during several basic activities of daily living using a computational model of the lower back. Following an initial assessment, the investigators estimate the following available sample sizes for each activity of daily living: (transfemoral-TFA, transtibial-TTA, and Controls-CTL ) 1) level ground walking at four different speeds (nTFA= 57, nTTA= 53, nCTL= 32), 2) sitting-to-standing and standing-to-sitting (nTFA= 29, nTTA= 20, nCTL= 15), and 3) stair ascending and descending tasks (nTFA= 18, nTTA= 20, nCTL= 15).
Key inclusion criteria (7 listed)
- For individuals with amputation
- unilateral amputation resulting from traumatic injuries (with no upper-extremity amputations)
- evaluation took place at least 6 months post-injury
- no assistive device use (e.g., canes, walkers, crutches)
- able-bodied individuals without amputation
Key exclusion criteria (7 listed)
- musculoskeletal impairments in the contralateral limb
- neurologic disorder or traumatic brain injury that would affect gait and movement
- pain levels greater than 3 out of 10 on a visual analog scale
- a history of spinal pathologies/LBP prior to injury.
- For controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity of daily livingwalking, sitting-to-standing and standing-to-sitting, stairs ascending and descending | Other | Controls, Transfemoral lower limb amputation, Transtibial lower limb amputation |
Primary outcome
Maximum value of summation of predicted forces in all trunk muscles
Time frame: At least 6 months post-injury
All outcome measures are obtained from computational simulation of data collected in previous studies.
Maximum spinal load at the lowest level of lumbar spine
Time frame: At least 6 months post-injury
All outcome measures are obtained from computational simulation of data collected in previous studies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Bazrgari, PhD principal investigator
University of Kentucky
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Kentucky.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum value of summation of predicted forces in all trunk muscles (time frame: At least 6 months post-injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.