The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation (NCT07626294) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation
Ukraine300 participantsStarted 2026-09-15
Plain-language summary
Patients with combat-related lower limb amputations frequently experience chronic low back pain during long-term rehabilitation and prosthetic use. Altered biomechanics, asymmetric loading, gait disturbances, and changes in spinal alignment after limb loss may contribute to the development of persistent back pain. The severity and characteristics of low back pain may vary according to the level of amputation.
The LEVEL-BACK Study is a prospective observational study designed to evaluate the relationship between amputation level and chronic low back pain after combat-related amputation.
Participants with different levels of lower limb amputation will undergo clinical assessment of low back pain intensity, functional limitations, prosthesis use, and rehabilitation outcomes during follow-up.
The goal of the study is to improve understanding of how amputation level influences chronic low back pain after combat-related limb loss and to identify patients at increased risk for persistent spinal pain during rehabilitation.
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:
* Age ≥18 years
* Combat-related lower limb amputation
* Transtibial, transfemoral, or bilateral lower limb amputation
* Time since amputation ≥3 months
* Current or planned prosthesis use
* Ability to participate in rehabilitation assessment
* Ability to report low back pain intensity
* Ability to provide written informed consent
Exclusion Criteria:
* Traumatic spinal injury related to the initial combat trauma
* Previous spinal surgery before amputation
* Known severe spinal deformity
* Active spinal infection or malignancy
* Severe neurological disorder affecting mobility
* Non-combat-related amputation
* Inability to complete follow-up assessments
* Refusal or inability to provide informed consent
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.
1Since this study is not yet recruiting, how long do I realistically need to wait before I could potentially participate, and would waiting affect my current treatment plan for low back pain?
2This trial is looking at whether the level of amputation is connected to chronic low back pain — based on what you know about my specific amputation level, do you think I'm likely to benefit from being part of this kind of research?
3Since this appears to be an observational study measuring changes in low back pain intensity rather than testing a new treatment, would joining this trial actually change the care I receive, or would I just be contributing data while continuing my current treatment?
4Are there existing treatments or rehabilitation approaches for combat-related amputation and chronic low back pain that I should be trying now, rather than waiting to see if this study opens up?
5What does it mean practically for me to be in a study like this — would I need to come in for extra visits, answer surveys over time, or undergo any procedures to have my pain levels measured?
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
Change in chronic low back pain intensity
Timeframe: Baseline to 12 months
Trial details
NCT IDNCT07626294
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy