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NCT05318508 Clinical Trial

Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Low Back Pain Clinical Trial

Official title:
Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05318508
Other study ID # E2-21-1002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 10, 2022
Est. completion date June 20, 2023

Study information
Verified date May 2024
Source Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 20, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Measurements of sagittal spinopelvic parameters
Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.

Locations
Country Name City State
Turkey Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Thoracic kyphosis 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. baseline
Secondary Cervical lordosis baseline
Secondary Lumbar lordosis baseline
Secondary Pelvic tilt baseline
Secondary Pelvic incidence baseline
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