Kinesiophobia in Patients With Chronic Low Back Pain

NCT ID: NCT06190041

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-10

Study Completion Date

2024-05-30

Brief Summary

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Low back pain is an important health problem that is common in public and causes serious socio-economic losses. Low back pain that persists for more than 12 weeks is defined as chronic low back pain. The prognosis in patients with chronic low back pain is generally not good and it significantly affects the patient's daily living activities and workforce. In the clinical course of chronic low back pain, patients generally reduce some activities or avoid them altogether due to fear of pain or concern about worsening of the initial lesion. This fear is called "kinesiophobia", which is an important factor in the chronicity of low back pain and the resulting functional disabilities. Kinesiophobia causes loss of flexibility, decreased muscle performance, muscle wasting, and all of these lead to a decrease in social and physical activities, which perpetuates and aggravates the disability. The aim of this study is to determine the relationship between the frequency of kinesiophobia in chronic low back pain patients and age, gender, body mass index, educational status, occupation, pain intensity and disability, and to examine the effect of kinesiophobia on quality of life.

Detailed Description

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Approximately 200 patients with chronic low back pain lasting ≥12 weeks between the ages of 18-75 who applied to the outpatient clinic will be included in the study. Demographic data of the patients such as age, gender, body mass index and occupation will be recorded. The pain intensity of the patients will be evaluated with the Visual Analog Scale (VAS), their disability with the Oswestry disability index, their kinesiophobia with the Tampo scale for kinesiophobia (TSK), and their quality of life with the SF 36 quality of life scale. TSK is a 17-question scale developed to measure the fear of movement/re-injury. The scale has four answer options rated on a Likert scale (1=Strongly Disagree, 2=Disagree, 3=Agree, 4=Strongly Agree). The total score varies between 17 and 68. Oswestry disability index will be used to measure the person's level of functional disability in individuals with low back pain. Oswestry disability index includes ten subheadings: severity of pain, personal care, lifting loads, walking, sitting, standing, sleeping, sexual life, social life and travel. Each question is given a score between 0 (no disability) and 5 (full disability). The total score varies between 0 (no disability) and 50 (full disability). As the total score increases, functional status worsens. SF-36 short form index will be used to measure quality of life. SF 36 Short form is a questionnaire that provides wide-angle measurement within the quality of life scales and has a generic criterion feature. It consists of 36 questions in 8 categories under the headings of physical function, physical role difficulty, social function, mental health, vitality, pain, emotional role difficulty and general health. The answers to the questions are added as positive and negative and the total score varies between 0 and 100. A high score indicates good health.

Conditions

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Kinesiophobia Disability Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

1. Having mechanic lower back pain lasting more than 12 weeks
2. VAS score ≥4
3. Being between the ages of 18-75

Exclusion Criteria

1. Having inflammatory lower back pain
2. Presence of oncological disease
3. Pregnancy
4. Presence of infection
5. Presence of recent trauma and/or lumbar fracture affecting the lumbar spine
6. Presence of neurological disease that will affect movement
7. Presence of rheumatic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Duygu Karamanlıoğlu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunus Emre Doğan

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Feyza Akan Begoglu

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Gulcan Ozturk

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Meryem Yilmaz Kaysin

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Feyza Unlu Ozkan

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Ilknur Aktas

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Central Contacts

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Duygu Silte Karamanlioglu

Role: CONTACT

00905323074990

Yunus Emre Dogan

Role: CONTACT

00905060512500

Other Identifiers

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FSMEAH-KAEK 2023/37

Identifier Type: -

Identifier Source: org_study_id

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