KinesiophobiaNCT06190041
Kinesiophobia in Patients With Chronic Low Back Pain
An observational study of Kinesiophobia and Disability, run by Fatih Sultan Mehmet Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kinesiophobia, Disability, Quality of Life
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2024to 30 May 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic mechanic low back pain
Who may be able to join
- Having mechanic lower back pain lasting more than 12 weeks
- VAS score ≥4
- Being between the ages of 18-75
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kinesiophobia, Disability, Quality of Life
- Keywords
- chronic low back pain, Kinesiophobia, Disability
- Medical subject headings
- Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Mar 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Karamanlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Yunus Emre Doğan, Study chair, Fatih Sultan Mehmet Training and Research HospitalFeyza Akan Begoglu, Study chair, Fatih Sultan Mehmet Training and Research HospitalGulcan Ozturk, Study chair, Fatih Sultan Mehmet Training and Research HospitalMeryem Yilmaz Kaysin, Study chair, Fatih Sultan Mehmet Training and Research HospitalFeyza Unlu Ozkan, Study chair, Fatih Sultan Mehmet Training and Research HospitalIlknur Aktas, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190041
- Sponsor's protocol ID
- FSMEAH-KAEK 2023/37
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia in Patients With Chronic Low Back Pain: an Evaluation on Relevant Factors and Its Effects on Quality of Life
- ClinicalTrials.gov ID
- NCT06190041
- Acronym / sponsor ID
- FSMEAH-KAEK 2023/37
- Conditions
- Kinesiophobia, Disability, Quality of Life
- Keywords
- chronic low back pain, Kinesiophobia, Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic mechanic low back pain
Key inclusion criteria (3 listed)
- Having mechanic lower back pain lasting more than 12 weeks
- VAS score ≥4
- Being between the ages of 18-75
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinesiophobia in patients with chronic low back pain
Time frame: 3 months
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.
Disability in patients with chronic low back pain
Time frame: 3 months
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.
Quality of life in patients with chronic low back pain
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Kinesiophobia
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Musculoskeletal Pain, Chronic Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunus Emre Doğan study chair
Fatih Sultan Mehmet Training and Research Hospital
Feyza Akan Begoglu study chair
Fatih Sultan Mehmet Training and Research Hospital
Gulcan Ozturk study chair
Fatih Sultan Mehmet Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Kinesiophobia and Disability, run by Fatih Sultan Mehmet Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Silte Karamanlioglu (00905323074990, drduygusilte@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia in patients with chronic low back pain (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.