NCT05318508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

March 28, 2022

Last Update Submit

May 13, 2024

Conditions

Amputation, TraumaticLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cervical lordosis

    baseline

  • Lumbar lordosis

    baseline

  • Pelvic tilt

    baseline

  • Pelvic incidence

    baseline

Study Arms (2)

patients with low back pain

Other: Measurements of sagittal spinopelvic parameters

patients without low back pain

Other: Measurements of sagittal spinopelvic parameters

Interventions

Measurements of sagittal spinopelvic parametersOTHER

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

patients with low back painpatients without low back pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lower extremity amputation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amputation, TraumaticLow Back Pain

Condition Hierarchy (Ancestors)

Wounds and InjuriesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 8, 2022

Study Start

April 10, 2022

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

TU(1)