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The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation (LEVEL-BACK)

30. maj 2026 opdateret af: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Ukraine
      • Vinnytsia, Ukraine, 21000
        • Vinnitsya university hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will include adult patients with combat-related lower limb amputations undergoing rehabilitation and prosthetic recovery. The study population will consist of individuals with unilateral transtibial amputation, unilateral transfemoral amputation, or bilateral lower limb amputation. Participants will be recruited from military rehabilitation and trauma centers specializing in post-amputation care. The study aims to evaluate the relationship between amputation level and chronic low back pain during long-term rehabilitation and prosthesis use.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Transtibial Amputation
Participants with unilateral transtibial (below-knee) combat-related lower limb amputation.
Transfemoral Amputation
Participants with unilateral transfemoral (above-knee) combat-related lower limb amputation
Bilateral Lower Limb Amputation
Participants with bilateral combat-related lower limb amputation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in chronic low back pain intensity
Tidsramme: Baseline to 12 months
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.
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Low Back Pain Disability Assessed Using the Oswestry Disability Index (ODI)
Tidsramme: Baseline, 3 months, 6 months, and 12 months after amputation.

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.
Low Back Pain Disability Assessed Using the Roland-Morris Disability Questionnaire (RMDQ)
Tidsramme: Baseline, 3 months, 6 months, and 12 months after amputation.

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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

15. september 2026

Studieafslutning (Anslået)

15. september 2026

Datoer for studieregistrering

Først indsendt

23. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11v313022026
  • USRA (Anden identifikator: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data including demographic characteristics, amputation level, low back pain intensity scores, functional mobility assessments, prosthesis use data, rehabilitation outcomes, analgesic consumption, and follow-up clinical evaluations collected during the study will be available for sharing. The study protocol, statistical analysis plan, and analytic code may also be shared upon reasonable request.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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