NCT07629466

Brief Summary

The Trendelenburg sign is a common clinical finding indicating hip abductor dysfunction and altered pelvic stability. The relationship between the Trendelenburg sign, spinopelvic biomechanics, hip muscle strength, and lumbar magnetic resonance imaging (MRI) abnormalities remains insufficiently understood. This study aims to investigate the association between Trendelenburg sign positivity and lumbar MRI findings, including facet arthropathy, ligamentum flavum hypertrophy, multifidus muscle morphology, and psoas muscle characteristics, as well as spinopelvic biomechanical parameters and hip abductor muscle strength.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

June 1, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 4, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Expected
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 1, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence and Severity of Lumbar Facet Joint Arthropathy

    Assessment of the presence and severity of lumbar facet joint arthropathy on magnetic resonance imaging (MRI) and its association with Trendelenburg sign positivity.

    Baseline

Eligibility Criteria

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

Adults aged 18-65 years with low back pain and available lumbar MRI scans obtained within the previous 12 months. Participants will undergo clinical assessment for Trendelenburg sign and hip function, and lumbar MRI evaluation for degenerative changes.

You may qualify if:

  • Age between 18 and 65 years.
  • Patients who have previously presented to the clinic with a complaint of low back pain.
  • Willingness and ability to provide written informed consent for participation in the study.
  • Availability of lumbar MRI images obtained within the previous 12 months and accessible for evaluation.

You may not qualify if:

  • Presence of red flag conditions associated with low back pain, including malignancy, infection, acute trauma, or significant neurological deficits.
  • History of lumbar spine surgery.
  • Structural spinal anomalies such as sacralization or lumbarization.
  • Spinal deformities, including scoliosis.
  • Rheumatologic diseases affecting the spine (e.g., axial spondyloarthritis).
  • Significant radiculopathy or advanced neurological deficits, and the presence of extruded or sequestrated lumbar disc herniation.
  • Clinically significant lumbar spinal stenosis.
  • Spondylolysis and/or spondylolisthesis.
  • Acute vertebral fracture, compression fracture, or recent fracture associated with severe osteoporosis.
  • Hip or pelvic conditions that may directly influence the Trendelenburg sign, including: History of hip arthroplasty or hip surgery, advanced hip osteoarthritis, residual deformity following lower-extremity fracture, significant leg length discrepancy (\>2 cm).
  • Systemic or neuromuscular disorders, including multiple sclerosis, myopathies, amyotrophic lateral sclerosis (ALS), stroke, or peripheral neuropathies.
  • Pregnancy.
  • Severe knee or ankle pathology or other conditions causing substantial gait impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir university

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

zeynep Iyigun, Prof. MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof., MD

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 4, 2026

Primary Completion

August 25, 2026

Study Completion (Estimated)

October 10, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional regulations.

Locations