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

30 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in chronic low back pain intensity
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Low Back Pain Disability Assessed Using the Oswestry Disability Index (ODI)
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 september 2026

Primärt slutförande (Beräknad)

15 september 2026

Avslutad studie (Beräknad)

15 september 2026

Studieregistreringsdatum

Först inskickad

23 maj 2026

Först inskickad som uppfyllde QC-kriterierna

30 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 11v313022026
  • USRA (Annan identifierare: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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