Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Completed

• Conditions: Amputation, Traumatic; Low Back Pain
• Interventions: Other: Measurements of sagittal spinopelvic parameters

• Registration Number: NCT05318508
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary

The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation.

Detailed Description

Low back pain is one of the secondary health problems that negatively affect functionality, independence and quality of life in individuals with lower extremity amputation. The prevalence of low back pain was reported to be higher in individuals with lower extremity amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low back pain is multifactorial, changing anatomy and biomechanics after lower extremity amputation and maintaining daily activities are often associated with the development of low back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine that contributes to low back pain, is considered to cause additional load on the spinal structures.

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-08
• Study Start: 2022-04-10
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients aged ≥ 18 and ≤ 65 years
• Patients followed for at least 12 months with lower extremity amputation
• Patients who have been using prosthesis for at least 3 months
• Patients with stable medical and psychological status
• Patients willing to participate in the study

Exclusion Criteria

• Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking
• Patients with severe vision, hearing and language problems

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with low back pain	Measurements of sagittal spinopelvic parameters	-
patients without low back pain	Measurements of sagittal spinopelvic parameters	-

Primary Outcome Measures

Name	Time	Method
Thoracic kyphosis	baseline	The angle between the line drawn perpendicular to the line through the T4 upper end plate and the lines drawn perpendicular to the line through the T12 lower end plate.

Secondary Outcome Measures

Name	Time	Method
Lumbar lordosis	baseline
Cervical lordosis	baseline
Pelvic tilt	baseline
Pelvic incidence	baseline

Trial Locations

Locations (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey