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

Sponsor
Ukrainian Society of Regional Anesthesia and Pain Therapy
Study ID
NCT07626294
Status
Not Yet Recruiting

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Conditions

  • Amputation
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
Sep 15, 2026
Status verified
May 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

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

Primary Outcome Measure

Change in chronic low back pain intensity [ Time Frame: Baseline to 12 months ]

Central Contacts

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