Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06190041 |
| Other study ID # |
FSMEAH-KAEK 2023/37 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2024 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Fatih Sultan Mehmet Training and Research Hospital |
| Contact |
Duygu Silte Karamanlioglu |
| Phone |
00905323074990 |
| Email |
drduygusilte[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
