Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

Sponsor
Hitit University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05318508
Collaborator
(none)
30
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurements of sagittal spinopelvic parameters

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
patients with low back pain

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

patients without low back pain

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Cervical lordosis [baseline]

  2. Lumbar lordosis [baseline]

  3. Pelvic tilt [baseline]

  4. Pelvic incidence [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hitit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuğba Atan, MD, Assoc. Prof, Hitit University
ClinicalTrials.gov Identifier:
NCT05318508
Other Study ID Numbers:
  • E2/AMPUTATION/2021
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022