Amputation, TraumaticNCT05318508
Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation
An observational study of Amputation, Traumatic and Low Back Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation, Traumatic, Low Back Pain
- What is being tested?
- Measurements of sagittal spinopelvic parameters
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2022to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lower extremity amputation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
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.
- Conditions
- Amputation, Traumatic, Low Back Pain
- Being tested
- Measurements of sagittal spinopelvic parameters
- Medical subject headings
- Amputation, Traumatic, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of sagittal spinopelvic parametersOther
Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.
| Study group | Role | What they receive |
|---|---|---|
| patients with low back pain | Not described Receives: Other: Measurements of sagittal spinopelvic parameters | |
| patients without low back pain | Not described Receives: Other: Measurements of sagittal spinopelvic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
Cervical lordosis
Measured: baseline
Lumbar lordosis
Measured: baseline
Pelvic tilt
Measured: baseline
Pelvic incidence
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Apr 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318508
- Sponsor's protocol ID
- E2-21-1002
- Status last verified
- May 2024
- First submitted
- 28 Mar 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Atan T, Kalem Ozgen AN, Gultekin VO, Demir Y, Guzelkucuk U, Aydemir K, Koyuncu E. Sagittal spinopelvic parameters in lower extremity amputees with and without low back pain. Prosthet Orthot Int. 2026 Aug 6. doi: 10.1097/PXR.0000000000000580. Online ahead of print.
PubMed 42566760
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT05318508
- Acronym / sponsor ID
- E2-21-1002
- Conditions
- Amputation, Traumatic, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with low back pain | – | Other: Measurements of sagittal spinopelvic parameters |
| patients without low back pain | – | Other: Measurements of sagittal spinopelvic parameters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lower extremity amputation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of sagittal spinopelvic parametersSagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation. | Other | patients with low back pain, patients without low back pain |
Primary outcome
Thoracic kyphosis
Time frame: 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.
4 secondary outcomes
Cervical lordosis
Time frame: baseline
Lumbar lordosis
Time frame: baseline
Pelvic tilt
Time frame: baseline
Pelvic incidence
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 42566760Atan T, Kalem Ozgen AN, Gultekin VO, Demir Y, Guzelkucuk U, Aydemir K, Koyuncu E. Sagittal spinopelvic parameters in lower extremity amputees with and without low back pain. Prosthet Orthot Int. 2026 Aug 6. doi: 10.1097/PXR.0000000000000580. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic and Low Back Pain, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic kyphosis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.