Kinesiophobia in Patients With Chronic Low Back Pain

Kinesiophobia in Patients With Chronic Low Back Pain: an Evaluation on Relevant Factors and Its Effects on Quality of Life

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Disability; Kinesiophobia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Duygu Silte Karamanlioglu; Phone Number: 00905323074990; Email: drduygusilte@hotmail.com
• Study Contact Backup: Name: Yunus Emre Dogan; Phone Number: 00905060512500; Email: ynsemredgn91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic mechanic low back pain

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia in patients with chronic low back pain	Kinesiophobia will be assessed using the Turkish version of the Tampa Scale for kinesiophobia (TSK). 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.	3 months
Disability in patients with chronic low back pain	Oswestry disability index will be used to measure the person's level of functional disability in individuals with low back pain.Oswestry disability index is a test that measures the level of functional disability in individuals with low back pain. It 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.	3 months
Quality of life in patients with chronic low back pain	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.	3 months

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Study Chair: Yunus Emre Doğan, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Feyza Akan Begoglu, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Gulcan Ozturk, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Meryem Yilmaz Kaysin, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Feyza Unlu Ozkan, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Ilknur Aktas, Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic low back pain; Kinesiophobia; Disability
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Phobic Disorders; Back Pain; Low Back Pain; Kinesiophobia
• Other Study ID Numbers: FSMEAH-KAEK 2023/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No