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CompletedNCT05318508Updated May 14, 2024

Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation

An observational study in Amputation, Traumatic and Low Back Pain, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Amputation, Traumatic
  • Low Back Pain
03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's enrollment of 30 is below the median of 37 across 34 observational studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 85 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Lower extremity amputation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with low back pain

    Other: Measurements of sagittal spinopelvic parameters

  • patients without low back pain

    Other: Measurements of sagittal spinopelvic parameters

Interventions

  • OtherMeasurements of sagittal spinopelvic parameters

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

06

What researchers measure

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.

    Time frame: baseline

Secondary outcomes

  1. Cervical lordosis

    Time frame: baseline

  2. Lumbar lordosis

    Time frame: baseline

  3. Pelvic tilt

    Time frame: baseline

  4. Pelvic incidence

    Time frame: baseline

07

Study locations

1 site
  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Jun 2023, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2022
First posted
Apr 8, 2022
StartActual
Apr 10, 2022
Primary completionActual
Jun 20, 2023
CompletionActual
Jun 20, 2023
Last update
May 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05318508
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Tuğba Atan, MD (Assoc. Prof, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Apr 8, 2022
Start date
Apr 10, 2022
Primary completion
Jun 20, 2023
Completion
Jun 20, 2023
Last update
May 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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