Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

NCT ID: NCT05318508

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-10

Study Completion Date

2023-06-20

Brief Summary

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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

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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.

Conditions

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Amputation, Traumatic Low Back Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with low back pain

Measurements of sagittal spinopelvic parameters

Intervention Type OTHER

Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.

patients without low back pain

Measurements of sagittal spinopelvic parameters

Intervention Type OTHER

Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.

Interventions

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Measurements of sagittal spinopelvic parameters

Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Atan, MD

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E2-21-1002

Identifier Type: -

Identifier Source: org_study_id

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