The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation (LEVEL-BACK)
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.
Обзор исследования
Статус
Условия
Подробное описание
Chronic low back pain is a common long-term complication following lower limb amputation and may significantly impair mobility, rehabilitation, prosthesis tolerance, and quality of life. Patients with combat-related amputations are particularly vulnerable because of severe tissue trauma, altered gait mechanics, asymmetric loading, repeated surgical interventions, and prolonged rehabilitation.
Biomechanical alterations after amputation may lead to abnormal spinal loading, pelvic asymmetry, trunk compensation, and increased energy expenditure during ambulation. These changes may contribute to chronic mechanical stress on the lumbar spine and development of persistent low back pain. The level of amputation may play an important role in this process, as more proximal amputations are frequently associated with greater gait disturbance, increased compensatory trunk movements, and higher biomechanical demand during prosthetic walking.
Despite increasing recognition of chronic low back pain after amputation, limited prospective data are available regarding the relationship between amputation level and spinal pain severity in combat-related trauma populations.
The LEVEL-BACK Study is a prospective observational study designed to evaluate the association between lower limb amputation level and chronic low back pain after combat-related amputation.
Participants with transtibial, transfemoral, and bilateral lower limb amputations will undergo longitudinal clinical assessment during rehabilitation follow-up. Study evaluations will include assessment of low back pain intensity, duration of symptoms, prosthesis use, functional mobility, rehabilitation outcomes, and pain-related disability.
The study aims to improve understanding of spinal pain mechanisms after combat-related limb loss and identify patient groups at increased risk for chronic low back pain according to amputation level.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Dmytro Dmytriiev, PhD.Professor
- Номер телефона: +380674309449
- Электронная почта: mddmytriiev@gmail.com
Места учебы
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Vinnytsia, Украина, 21000
- Vinnitsya university hospital
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Контакт:
- Dmytro Dmytriiev, Phd
- Номер телефона: 0674309449
- Электронная почта: mddmytriiev@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Transtibial Amputation
Participants with unilateral transtibial (below-knee) combat-related lower limb amputation.
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Transfemoral Amputation
Participants with unilateral transfemoral (above-knee) combat-related lower limb amputation
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Bilateral Lower Limb Amputation
Participants with bilateral combat-related lower limb amputation.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in chronic low back pain intensity
Временное ограничение: Baseline to 12 months
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Assessment of change in low back pain intensity using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Baseline to 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Low Back Pain Disability Assessed Using the Oswestry Disability Index (ODI)
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after amputation.
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Low back pain-related disability will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire designed to evaluate functional impairment associated with low back pain. The ODI consists of 10 sections covering pain intensity and activities of daily living. Total scores range from 0 to 100, with higher scores indicating greater disability and worse functional status. Scale Information: Oswestry Disability Index (ODI) Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate greater low back pain-related disability and worse functional outcomes. |
Baseline, 3 months, 6 months, and 12 months after amputation.
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Low Back Pain Disability Assessed Using the Roland-Morris Disability Questionnaire (RMDQ)
Временное ограничение: Baseline, 3 months, 6 months, and 12 months after amputation.
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Low back pain-related disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ), a validated 24-item patient-reported outcome measure designed to evaluate functional limitations associated with low back pain. Participants indicate whether each statement applies to them on the day of assessment. Total scores range from 0 to 24, with higher scores indicating greater disability and worse functional status. Scale Information: Roland-Morris Disability Questionnaire (RMDQ) Minimum Value: 0 Maximum Value: 24 Interpretation: Higher scores indicate greater disability related to low back pain and worse functional outcomes. |
Baseline, 3 months, 6 months, and 12 months after amputation.
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 11v313022026
- USRA (Другой идентификатор: Ukranian Society of Regional Anesthesia and Pain Therapy)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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