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

NCT07856498 | Not Yet Recruiting

• 1 other identifier: E-10840098-50.04-5398
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Postmenopause Women

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At the single assessment visit (Day 1).

• Functional Lower-Limb Performance Assessed by the 30-Second Chair Stand Test

  At the single assessment visit (Day 1).

• Functional Mobility Assessed by the Timed Up and Go Test

  At the single assessment visit (Day 1).

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

TU (1)