- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549009
Uterine Position and Pain and Central Sensitization Parameters in Women With Chronic Low Back Pain
The Relationship Between Uterine Position and Pain and Central Sensitization Parameters in Women With Chronic Low Back Pain
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34192
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group 1
Retrovert uterus
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No intervention
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Group 2
Antevert uterus
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline
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Pain intensity will be assessed using a 10-cm visual analog scale, where higher scores indicate greater pain severity.
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Baseline
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Central Sensitization Inventory (CSI)
Time Frame: Baseline
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CSI scores range from 0 to 100, with higher scores indicating greater central sensitization.
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Baseline
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Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
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The PCS assesses catastrophic thinking related to pain.
Higher scores indicate greater pain catastrophizing.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- istftreah155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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