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

May 30, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in chronic low back pain intensity
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Back Pain Disability Assessed Using the Oswestry Disability Index (ODI)
Time Frame: 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)
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

May 23, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11v313022026
  • USRA (Other Identifier: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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