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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Low Back Pain

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