The Impact of Unilateral Lower Limb Amputation on Spinal Loads (NCT02897973) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Unilateral Lower Limb Amputation on Spinal Loads
173 participantsStarted 2011-09
Plain-language 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. 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum value of summation of predicted forces in all trunk muscles
Timeframe: At least 6 months post-injury
2
Maximum spinal load at the lowest level of lumbar spine