Kinesiophobia in Patients With Chronic Low Back Pain

NCT06190041 | Not Yet Recruiting

• 1 other identifier: FSMEAH-KAEK 2023/37
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kinesiophobia; Disability; Quality of Life

Keywords

chronic low back pain; Kinesiophobia; Disability

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic mechanic low back pain

You may qualify if:

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

You may not qualify if:

• Having inflammatory lower back pain
• Presence of oncological disease
• Pregnancy
• Presence of infection
• Presence of recent trauma and/or lumbar fracture affecting the lumbar spine
• Presence of neurological disease that will affect movement
• Presence of rheumatic disease

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• 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 CHAIR

Central Study Contacts

Duygu Silte Karamanlioglu

CONTACT

00905323074990; drduygusilte@hotmail.com

Yunus Emre Dogan

CONTACT

00905060512500; ynsemredgn91@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: March 10, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share