Low Back PainNCT07856498
Pain Catastrophizing, Fear of Movement, and Physical Activity in Postmenopausal Women With Chronic Low Back Pain
An observational study of Low Back Pain and Postmenopause Women, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to examine the relationships between pain catastrophizing, fear of movement, and physical activity in postmenopausal women with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Low Back Pain, Postmenopause Women
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Naturally postmenopausal women aged 45-65 years with nonspecific low back pain lasting at least three months. Natural postmenopause is defined as at least 12 consecutive months without menstruation, without another apparent physiological or pathological cause or a clinical intervention explaining amenorrhea. Nonspecific low back pain will be confirmed by physician assessment. Eligible women will be invited consecutively to participate in the study, with a target enrollment of 150 participants.
Who may be able to join
- Women aged 45 to 65 years.
- Natural postmenopause, defined as at least 12 consecutive months without menstruation, with no other apparent physiological or pathological cause and no clinical intervention explaining the absence of menstruation, confirmed by medical history and available medical records.
- Low back pain lasting at least three months, with no specific underlying cause identified through physician assessment.
- Ability to read and understand Turkish, provide informed consent, and follow the assessment instructions.
- Provision of written informed consent.
Who cannot join
- Surgically or medically induced menopause.
- Active malignancy, or a vertebral compression fracture, infection, inflammatory spinal disease, or another specific condition explaining the low back pain.
- Physician-confirmed radiculopathy, a marked neurological deficit, or lumbar spinal stenosis accompanied by neurogenic claudication.
- A severe neurological, rheumatological, or orthopedic disorder, or major surgery within the previous six months, that prevents safe or valid assessment.
- Cardiopulmonary disease or an acute medical condition that substantially limits physical activity or makes the physical performance assessments unsafe.
- Significant cognitive impairment or an acute or severe psychiatric condition that prevents valid informed consent or understanding of the assessment instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Istanbul, 34815
Gizem Boztaş Elverişli, 05439076494, gboztas@medipol.edu.tr
About this study
Official title: Investigation of the Relationship Between Pain Catastrophizing, Kinesiophobia, and Physical Activity in Postmenopausal Women With Chronic Nonspecific Low Back Pain: A Cross-Sectional Study
This observational study aims to examine the relationships between pain catastrophizing, fear of movement, and physical activity in postmenopausal women with chronic nonspecific low back pain. Pain catastrophizing refers to negative thoughts and feelings about pain, while fear of movement refers to concerns that movement may cause pain or injury.
The study will include 150 naturally postmenopausal women aged 45-65 years who have experienced nonspecific low back pain for at least three months. Participants will attend a single face-to-face assessment conducted by a trained physiotherapist. Questionnaires will assess physical activity, pain catastrophizing, fear of movement, low back pain intensity, disability symptoms. Functional mobility and lower-limb functional performance will be assessed using the Timed Up and Go test and the 30-second chair stand test.
The primary objective is to examine the joint association of pain catastrophizing and fear of movement with physical activity, accounting for relevant clinical and psychological factors. Secondary objectives concern disability and physical performance. No treatment will be assigned as part of the study.
Read the detailed description
Average low back pain intensity during the previous seven days will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (the worst imaginable pain). The assessment will refer specifically to the low back region.
- Conditions
- Low Back Pain, Postmenopause Women
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Women With Chronic Nonspecific Low Back Pain | Naturally postmenopausal women aged 45-65 years with nonspecific low back pain lasting at least three months. Participants will undergo a single face-to-face assessment by a trained physiotherapist. Questionnaires will assess physical activity, pain catastrophizing, kinesiophobia, low back pain intensity, disability symptoms. Functional mobility and lower-limb functional performance will be assessed using the Timed Up and Go test and the 30-second chair stand test. No treatment will be assigned as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Physical Activity Assessed by the International Physical Activity Questionnaire Short Form
Self-reported physical activity will be assessed using the Turkish version of the International Physical Activity Questionnaire Short Form (IPAQ-SF). Walking, moderate-intensity activity, and vigorous-intensity activity during the previous seven days will be scored according to the standard IPAQ scoring protocol and summed to obtain total MET-minutes per week. Sitting time will be recorded separately and will not contribute to the total physical activity score. Higher values indicate greater reported physical activity.
Measured: At the single assessment visit (Day 1), referring to physical activity during the previous 7 days.
Secondary outcomes (3)
Low Back Pain-Related Disability Assessed by the Oswestry Disability Index
Low back pain-related disability will be assessed using the Turkish version of the Oswestry Disability Index. The questionnaire consists of 10 sections scored from 0 to 5. The total score will be expressed as a percentage of the maximum possible score for the valid, completed sections, following the scoring rules of the version used. Scores range from 0% to 100%, with higher scores indicating greater disability.
Time Frame:
Measured: At the single assessment visit (Day 1).
Functional Lower-Limb Performance Assessed by the 30-Second Chair Stand Test
Functional lower-limb performance will be assessed by the number of chair stands completed during one recorded 30-second trial. Participants will use an armless chair approximately 43 cm high, with their feet on the floor and arms crossed over the chest. A final repetition will be counted if the participant is more than halfway through standing when the time ends. Higher counts indicate better performance. Inability to stand without arm support will be scored as zero. Tests that cannot be started or must be stopped for safety reasons will be recorded as missing, with the reason documented.
Measured: At the single assessment visit (Day 1).
Functional Mobility Assessed by the Timed Up and Go Test
Functional mobility will be assessed by the time, in seconds, required to rise from a standard armchair, walk 3 meters at the usual pace, turn, return to the chair, and sit down. Timing will begin with the start command and end when the participant is seated again. Participants will wear their usual footwear, and use of a customary walking aid will be documented. Longer completion times indicate poorer functional mobility.
Measured: At the single assessment visit (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start28 Sep 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem boztas, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856498
- Sponsor's protocol ID
- E-10840098-50.04-5398
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is currently no plan to share individual participant data. Study findings will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Pain Catastrophizing, Kinesiophobia, and Physical Activity in Postmenopausal Women With Chronic Nonspecific Low Back Pain: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07856498
- Acronym / sponsor ID
- E-10840098-50.04-5398
- Conditions
- Low Back Pain, Postmenopause Women
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 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.
This observational study aims to examine the relationships between pain catastrophizing, fear of movement, and physical activity in postmenopausal women with chronic nonspecific low back pain. Pain catastrophizing refers to negative thoughts and feelings about pain, while fear of movement refers to concerns that movement may cause pain or injury.
The study will include 150 naturally postmenopausal women aged 45-65 years who have experienced nonspecific low back pain for at least three months. Participants will attend a single face-to-face assessment conducted by a trained physiotherapist. Questionnaires will assess physical activity, pain catastrophizing, fear of movement, low back pain intensity, disability symptoms. Functional mobility and lower-limb functional performance will be assessed using the Timed Up and Go test and the 30-second chair stand test.
The primary objective is to examine the joint association of pain catastrophizing and fear of movement with physical activity, accounting for relevant clinical and psychological factors. Secondary objectives concern disability and physical performance. No treatment will be assigned as part of the study.
Detailed description
Average low back pain intensity during the previous seven days will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (the worst imaginable pain). The assessment will refer specifically to the low back region.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Women With Chronic Nonspecific Low Back Pain | – | –Naturally postmenopausal women aged 45-65 years with nonspecific low back pain lasting at least three months. Participants will undergo a single face-to-face assessment by a trained physiotherapist. Questionnaires will assess physical activity, pain catastrophizing, kinesiophobia, low back pain intensity, disability symptoms. Functional mobility and lower-limb functional performance will be assessed using the Timed Up and Go test and the 30-second chair stand test. No treatment will be assigned as part of the study. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Naturally postmenopausal women aged 45-65 years with nonspecific low back pain lasting at least three months. Natural postmenopause is defined as at least 12 consecutive months without menstruation, without another apparent physiological or pathological cause or a clinical intervention explaining amenorrhea. Nonspecific low back pain will be confirmed by physician assessment. Eligible women will be invited consecutively to participate in the study, with a target enrollment of 150 participants.
Key inclusion criteria (5 listed)
- Women aged 45 to 65 years.
- Natural postmenopause, defined as at least 12 consecutive months without menstruation, with no other apparent physiological or pathological cause and no clinical intervention explaining the absence of menstruation, confirmed by medical history and available medical records.
- Low back pain lasting at least three months, with no specific underlying cause identified through physician assessment.
- Ability to read and understand Turkish, provide informed consent, and follow the assessment instructions.
- Provision of written informed consent.
Key exclusion criteria (6 listed)
- Surgically or medically induced menopause.
- Active malignancy, or a vertebral compression fracture, infection, inflammatory spinal disease, or another specific condition explaining the low back pain.
- Physician-confirmed radiculopathy, a marked neurological deficit, or lumbar spinal stenosis accompanied by neurogenic claudication.
- A severe neurological, rheumatological, or orthopedic disorder, or major surgery within the previous six months, that prevents safe or valid assessment.
- Cardiopulmonary disease or an acute medical condition that substantially limits physical activity or makes the physical performance assessments unsafe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Physical Activity Assessed by the International Physical Activity Questionnaire Short Form
Time frame: At the single assessment visit (Day 1), referring to physical activity during the previous 7 days.
Self-reported physical activity will be assessed using the Turkish version of the International Physical Activity Questionnaire Short Form (IPAQ-SF). Walking, moderate-intensity activity, and vigorous-intensity activity during the previous seven days will be scored according to the standard IPAQ scoring protocol and summed to obtain total MET-minutes per week. Sitting time will be recorded separately and will not contribute to the total physical activity score. Higher values indicate greater reported physical activity.
3 secondary outcomes
Low Back Pain-Related Disability Assessed by the Oswestry Disability Index
Time frame: At the single assessment visit (Day 1).
Functional Lower-Limb Performance Assessed by the 30-Second Chair Stand Test
Time frame: At the single assessment visit (Day 1).
Functional Mobility Assessed by the Timed Up and Go Test
Time frame: At the single assessment visit (Day 1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided. There is currently no plan to share individual participant data. Study findings will be reported in aggregate form.
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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.
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 and Postmenopause Women, run by Istanbul Medipol University 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 6 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: looking for participants now, as of the sponsor's last update on 8 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Physical Activity Assessed by the International Physical Activity Questionnaire Short Form (time frame: At the single assessment visit (Day 1), referring to physical activity during the previous 7 days.). 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 8 Oct 2026.