The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Combat-related lower limb amputation

Transtibial, transfemoral, or bilateral lower limb amputation

Time since amputation ≥3 months

Disqualifiers

Traumatic spinal injury related to the initial combat trauma

Previous spinal surgery before amputation

Known severe spinal deformity

Active spinal infection or malignancy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Transtibial Amputation
Group B: Transfemoral Amputation
Group C: Bilateral Lower Limb Amputation

Trial outcomes

Primary outcomes

1

Change in chronic low back pain intensity

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.

Time frame
Baseline to 12 months

Secondary outcomes

1

Low Back Pain Disability Assessed Using the Oswestry Disability Index (ODI)

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.

Time frame
Baseline, 3 months, 6 months, and 12 months after amputation.
2

Low Back Pain Disability Assessed Using the Roland-Morris Disability Questionnaire (RMDQ)

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.

Time frame
Baseline, 3 months, 6 months, and 12 months after amputation.

Other outcomes

Sponsors and contacts

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