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Clinical Trials in Turkey / NCT07856498
Recruiting Observational

Pain Catastrophizing, Fear of Movement, and Physical Activity in Postmenopausal Women With Chronic Low Back Pain

NCT07856498 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istanbul Medipol University Hospital
Phase
Observational
Started
2026-09-28
Last updated
2026-10-08

Condition(s) studied

Low Back PainPostmenopause Women

Study 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

Sex
FEMALE
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Total Physical Activity Assessed by the International Physical Activity Questionnaire Short Form — 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.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University Istanbul Istanbul Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07856498 on ClinicalTrials.gov ↗ ← All trials in Turkey