Low Back PainNCT07549009
Uterine Position and Pain and Central Sensitization Parameters in Women With Chronic Low Back Pain
An observational study of Low Back Pain, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Low Back Pain
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 16 Apr 2026
- How long will I take part?
- 1 Day
- 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 75 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
Official title: 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).
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- No intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Retrovert uterus Receives: Other: No intervention | |
| Group 2 | Antevert uterus Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm visual analog scale, where higher scores indicate greater pain severity.
Measured: Baseline
Central Sensitization Inventory (CSI)
CSI scores range from 0 to 100, with higher scores indicating greater central sensitization.
Measured: Baseline
Pain Catastrophizing Scale (PCS)
The PCS assesses catastrophic thinking related to pain. Higher scores indicate greater pain catastrophizing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start16 Mar 2026
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549009
- Sponsor's protocol ID
- istftreah155
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Uterine Position and Pain and Central Sensitization Parameters in Women With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07549009
- Acronym / sponsor ID
- istftreah155
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 23 Apr 2026 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionRetrovert uterus |
| Group 2 | – | Other: No interventionAntevert uterus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| No interventionNo intervention | Other | Group 1, Group 2 |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: Baseline
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.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline
Central Sensitization Inventory (CSI)
Time frame: Baseline
Pain Catastrophizing Scale (PCS)
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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 Low Back Pain, run by Istanbul Physical Medicine Rehabilitation Training 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 1 inclusion and 1 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 23 Apr 2026. 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?
Pressure Pain Threshold (PPT) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.