An observational study in Low Back Pain and Postmenopause Women, sponsored by Istanbul Medipol University Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Istanbul Medipol University Hospital · Observational
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 475 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: At the single assessment visit (Day 1), referring to physical activity during the previous 7 days.
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:
Time frame: 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.
Time frame: 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.
Time frame: At the single assessment visit (Day 1).
Plan to share: Undecided — There is currently no plan to share individual participant data. Study findings will be reported in aggregate form.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Medipol University Hospital