Investigation of factors affecting fear of movement in patients with knee osteoarthritis
| ISRCTN | ISRCTN10989223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10989223 |
| Protocol serial number | N/A |
| Sponsor | Baskent University |
| Funder | Investigator initiated and funded |
- Submission date
- 08/05/2018
- Registration date
- 13/05/2018
- Last edited
- 02/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee osteoarthritis (OA) is a common disease that affects daily life activities with pain and disturbs quality of life and creates fear of movement in the person. People with knee osteoarthritis often prefer to avoid daily activities that can cause their pain to start, such as frequent standing up, going up and down stairs, and doing tasks that require the knee to bend. Severe every-day pain and fear and anxiety associated with pain lead to disturbance of activity and depression, all of which contribute to reduced mobility and further impairment of quality of life. There are, however, a limited number of studies examining the factors that are linked to fear of movement in people with knee OA. In these studies, there is no examination of which factor is most important. The purpose of this research was to investigate the factors that cause fear of movement in people with knee osteoarthritis and to create guidance for doctors to take into account when making treatment decisions. The aim is to reduce fear of movement that keeps the person from daily life.
Who can participate?
People aged 40-80 with knee osteoarthritis
What does the study involve?
Patients were asked to rate rest, activity, and night pain severity. The strength of the leg muscles and the range of motion of the leg joints were evaluated by the researcher. The researcher also used movement tests to assess balance and movement ability in the patients. Patients were asked to fill out questionnaires relating to fear of movement, osteoarthritis severity, depression and quality of life. All patients were assessed only once and all assessments lasted approximately 60 minutes.
What are the possible benefits and risks of participating?
It is not expected that volunteers will benefit directly or that their course of treatment will change. However, the results obtained from this study may contribute to the planning of treatment of other patients with osteoarthritis.
Where is the study run from?
Baskent University Hospital
When is the study starting and how long is it expected to run for?
January 2018 to May 2018
Who is funding the study?
This study was initiated and funded by the investigator.
Who is the main contact?
Dr Emel Sonmezer, emelsonmezer@gmail.com
Contact information
Scientific
Bağlica Kampusu Fatih Sultan Mahallesi Eskişehir Yolu 18.km Baglica/Etimesgut
Ankara
06790
Türkiye
| Phone | 00903122466666 |
|---|---|
| emelsonmezer@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single-center observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | What are the factors associated with kinesiophobia in patients with knee osteoarthritis? |
| Study objectives | This study was designed to test the hypotheses that kinesiophobia is related to quality of life, disability, pain intensity, muscle strength, range of motion, physical activity level, balance, mobility, depression and anxiety. |
| Ethics approval(s) | Baskent University Clinical Trials Ethical Committee, 05/04/2017, KA 17/39 |
| Health condition(s) or problem(s) studied | Kinesophobia in patients with knee osteoarthritis |
| Intervention | Personal demographic data was recorded after the patient was admitted to the clinic with adequate resting time. Patients were asked to rate rest, activity, and night pain severity. The strength of the leg muscles and the range of motion of the leg joints were evaluated by the researcher. The functional state and balance evaluations such as the Time Up and Go test, the Berg Balance Scale were applied by the researcher. Patients answered the Tampa Kinesiophobia Scale, Western Ontario and McMaster University Osteoarthritis Index, Hospital Anxiety Depression Scale and Nottingham Health Profiles questionnaires. All patients were assessed once and all assessments lasted approximately 60 minutes. |
| Intervention type | Other |
| Primary outcome measure(s) |
Kinesiophobia assessed using a transculturally adapted version of the Tampa Scale of Kinesiophobia (TSK), which was developed to measure the fear of movement/re-injury of patients. The 4-point Likert scale (from strongly disagree (score = 1) to strongly agree (score = 4)) is used on the scale. A high score (maximum 68) indicates that the patient’s fear of falls and movements is excessive. |
| Key secondary outcome measure(s) |
1. Pain Intensity. Knee pain severity was measured using the Visual Analog Scale (VAS) during activity and rest. The patients were asked to mark the pain levels they felt on a horizontal line of 100 mm. 0 indicated no pain and 100 indicated maximum pain, referring to intolerable pain. The point marked on the line was measured with a ruler, and the intensity of the pain felt by the persons was recorded in cm. |
| Completion date | 01/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Willing to participate in study 2. Aged 40-80 years 3. Diagnosed with grade 2-3 osteoarthritis according to Kellgren-Lawrence scoring |
| Key exclusion criteria | 1. Other neurological and musculoskeletal diseases that affect balance and muscle strength 2. Prior knee surgery 3. Severe comorbidities 4. Pregnancy |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 06/04/2018 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Ankara
06490
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/02/2022 | 02/03/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/03/2022: Publication reference added.
08/11/2019: Internal review.