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Fear of PainNCT03875040

Knee Osteoarthritis, Kinesiophobia and Physical Activity

An observational study of Fear of Pain and Knee Osteoarthritis, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in… Read more about this study

Who is it for?
Ages 50 to 75 years
What is being tested?
kinesiophobia
How many people
96 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2018to 20 Oct 2018
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All the patients presenting to Aksaray Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic between April 2018 and October 2018, who volunteered to participate in the study and fulfilled the inclusion criteria, completed the questionnaire forms.

Who may be able to join

  • knee osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain intensity over 20 mm on Visual Analog Scale-VAS

Who cannot join

  • knee operation, Malignant diseases Systemic infectious diseases inflammatory diseases Fibromyalgia syndrome physical therapy and/or a knee injection within the last three months antidepressants, pregabalin or duloxetine usage

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Aksaray Training and Research Hospital

    Aksaray, Merkez, 68200

Other trials in Turkey (Türkiye)

About this study

Official title: Is There a Relationship Between Kinesiophobia and Physical Activity Level in Patients With Knee Osteoarthritis?

Although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in these patients. In this study, we aimed to evaluate the levels of kinesiophobia and physical activity in patients with knee osteoarthritis and to investigate whether they were associated with demographic characteristics, body mass index, pain intensity, depression, disability, radiological grade, and quality of life.

Read the detailed description

A total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (OA) and knee pain lasting for more than three months (knee pain intensity over 20 mm on Visual Analog Scale-VAS) were included in the study. The severity of pain at night, pain at rest and activity-related pain was evaluated by Visual Analog Scale (VAS), kinesiophobia by Tampa Scale of Kinesiophobia (TSK) and Brief Fear of Movement Scale (BFOM), depression by the Beck Depression Inventory (BDI), disability by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), physical activity level by the International Physical Activity Questionnaire (IPAQ) short form and quality of life by the Short Form 12 Health Survey Questionnaire (SF-12). Age, gender, marital status, educational status, additional disease, drug history, and sociodemographic data such as BMI were obtained from the patients and recorded in the evaluation form.

Being tested
kinesiophobia
Keywords
kinesiophobia, osteoarthritis, fear of movement, tampa, physical inactivity
Medical subject headings
Osteoarthritis, Knee, Motor Activity, Kinesiophobia, Osteoarthritis, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kinesiophobiaBehavioural

    patients who have a high-level or low-level kinesiophobia have been evaluated.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tampa Scale of Kinesiophobia

    Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. Minimal and maximal scores could be between 17-68 points. Higher scores indicate higher levels of kinesiophobia.

    Measured: 4-8 minutes

  2. International Physical Activity Questionnaire Short Form

    This questionnaire consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 MET-minutes/week are proposed to be high level.Some activity is reported but not enough to meet categories of moderate or high levels, it is proposed to be low level.

    Measured: 5-10 minutes

  3. Beck Depression Inventory

    This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.

    Measured: 10 minutes

  4. Visual Analog Scale for the Evaluation of Pain

    For this evaluation, the patient is asked to mark his/her severity of pain on a horizontal 10-cm line with number 0 on one end representing "no pain" and number 10 on the other end indicating "very severe pain". Higher scores indicate higher levels of pain intensity.

    Measured: 0.5 minutes

  5. Short Form-12 Health Survey Questionnaire

    A scale used to evaluate the quality of life, consisting of 12 items inquiring general health, physical condition, physical limitations, mental status, social status, pain, energy and mental limitation over a total score of 100 points. SF-12 is an abbreviated version of SF-36 and has been proven to be reliable and valid. In this study, we evaluated the patients' total, physical and mental SF-12 scores

    Measured: 5 minutes

  6. Western Ontario and McMaster Universities Arthritis Index

    A 24-item measure that was developed to evaluate pain, joint stiffness and physical functions in individuals with knee and hip OA. A higher score indicates a higher level of pain, stiffness and functional limitation. In our study, we used the WOMAC total score.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2019
  2. Study start20 Apr 2018
  3. Primary completion20 Oct 2018
  4. Study completion20 Oct 2018

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03875040
Sponsor's protocol ID
2018/67
Status last verified
Mar 2019
First submitted
13 Mar 2019
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gunn AH, Schwartz TA, Arbeeva LS, Callahan LF, Golightly Y, Goode A, Hill CH, Huffman K, Iversen MD, Pathak A, Taylor SS, Allen KD. Fear of Movement and Associated Factors Among Adults With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1826-1833. doi: 10.1002/acr.23226. Epub 2017 Nov 6.

    PubMed 28371481

  • Shelby RA, Somers TJ, Keefe FJ, DeVellis BM, Patterson C, Renner JB, Jordan JM. Brief Fear of Movement Scale for osteoarthritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):862-71. doi: 10.1002/acr.21626. Epub 2012 Jan 30.

    PubMed 22290689

Questions about this trial

What is this clinical trial studying?

An observational study of Fear of Pain and Knee Osteoarthritis, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tampa Scale of Kinesiophobia (time frame: 4-8 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03875040, which also lists 2 linked publications.

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 Mar 2019.

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