NCT07856498 Pain Catastrophizing, Fear of Movement, and Physical Activity in Postmenopausal Women With Chronic Low Back Pain
| NCT ID | NCT07856498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Medipol University Hospital |
| Condition | Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-09-28 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-09-28 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07856498 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 65 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07856498 currently recruiting?
Yes, NCT07856498 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istanbul Medipol University Hospital to inquire about joining.
Where is the NCT07856498 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07856498 clinical trial?
NCT07856498 is sponsored by Istanbul Medipol University Hospital. The trial plans to enroll 150 participants.