NCT07549009

Brief Summary

Female patients aged 18-75 years with chronic low back pain (lasting at least 3 months) will be included in the study. Demographic data including age, height, weight, educational status, marital status, and comorbidities will be recorded. In addition, clinical characteristics such as pain duration, pain distribution, analgesic use, and concomitant musculoskeletal disorders will be assessed. Uterine position will be evaluated based on pelvic magnetic resonance imaging (MRI) or pelvic ultrasonography reports obtained within the last year. According to uterine position, participants will be divided into two groups: posteriorly positioned uterus (retroverted and/or retroflexed uterus) and anteriorly positioned uterus (anteverted uterus). Pain severity will be assessed using the Visual Analog Scale (VAS), and pain duration will be recorded in months. Pressure pain threshold measurements will be performed using an algometer at bilateral lumbar paraspinal muscles, gluteal regions, and the mid-deltoid muscle as a remote control point. Central sensitization will be assessed using the Central Sensitization Inventory (CSI), and pain catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS). All assessments will be conducted through face-to-face interviews. No additional laboratory tests, interventional procedures, or treatments will be applied to the participants within the scope of the study. Validated Turkish versions of all scales will be used. The collected data will be analyzed to investigate the relationship between uterine position and pressure pain threshold, central sensitization, and pain catastrophizing levels in women with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 16, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold (PPT)

    Pressure pain threshold (kg/cm²) will be measured using an algometer at bilateral lumbar paraspinal muscles, gluteal regions, and the mid-deltoid muscle as a remote control point. Lower values indicate increased pain sensitivity.

    Baseline

Secondary Outcomes (3)

  • Visual Analog Scale (VAS)

    Baseline

  • Central Sensitization Inventory (CSI)

    Baseline

  • Pain Catastrophizing Scale (PCS)

    Baseline

Study Arms (2)

Group 1

Retrovert uterus

Other: No intervention

Group 2

Antevert uterus

Other: No intervention

Interventions

No intervention

Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of female patients aged 18-75 years with chronic low back pain (lasting at least 3 months) who are admitted to the Physical Medicine and Rehabilitation outpatient clinics of Bakırköy Dr. Sadi Konuk Training and Research Hospital and Istanbul Physical Therapy and Rehabilitation Training and Research Hospital during the study period. Participants will be recruited consecutively. Only patients with available pelvic MRI and/or ultrasonography within the last year allowing classification of uterine position will be included. All participants will be medically stable and able to complete the study assessments.

You may qualify if:

  • Female, aged 18-75 years Presence of chronic low back pain (lasting at least 3 months) Availability of pelvic MRI and/or pelvic ultrasonography within the last year with assessable uterine position (anteverted, retroverted, retroflexed) Ability to read and understand Turkish and complete questionnaires Willingness to participate

You may not qualify if:

  • Pregnancy or childbirth within the last 6 months (postpartum period) History of lumbar spine surgery, vertebral fracture, or spinal malignancy Presence of inflammatory rheumatic disease (e.g., ankylosing spondylitis), severe neurological disease, or systemic disease affecting low back pain Severe cognitive impairment, communication problems, or major psychiatric disorder preventing participation Absence of pelvic imaging or inability to classify uterine position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 23, 2026

Study Start

March 16, 2026

Primary Completion

April 16, 2026

Study Completion

April 16, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations