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

NCT07626294 | Not Yet Recruiting DMC

• 2 other identifiers: 11v313022026USRA
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Amputation

Keywords

Chronic low back pain; Combat-related amputation; Amputation level; Transtibial amputation; Transfemoral amputation; Bilateral amputation; Prosthesis use; Rehabilitation

Outcome Measures

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.

  Baseline to 12 months

Secondary Outcomes (2)

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

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

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

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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Vinnitsya university hospital

Vinnytsia, 21000, Ukraine

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

UA (1)