KinesiophobiaNCT04314102
The Effect of Kinesiophobia on Spatio-temporal and Functionality in Total Knee Replacement Surgery
An observational study of Kinesiophobia and Knee Osteoarthritis, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kinesiophobia, Knee Osteoarthritis, Quality of Life
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 15 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with arthroplasty recommended for knee osteoarthritis
Who may be able to join
- Between 30-90 years old,
- Primary unilateral total knee replacement will be applied due to knee osteoarthritis,
- Patients volunteering to participate in the study
Who cannot join
- Who have neurological (hemiplegia, parkinson, multiplsclerosis etc.) disease that will affect functional performance and balance,
- Does not have cognitive function to allow active participation,
- Having a severe psychiatric condition,
- Severe vision and hearing loss,
- Any other treatment other than medication,
- Who have contralateral knee osteoarthritis (pain with activity 4/10 or higher),
Show all 9Show fewer
- Using drugs that can cause loss of balance,
- With more than 5 cm length difference in the lower extremities,
- Having undergone lower limb trauma or surgery in the past 1 year,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kinesiophobia on Spatio-temporal and Functionality in Individuals Who Have Undergone Total Knee Replacement Surgery
It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Although kinesiophobia is defined as the terms of "fear of movement" and "fear related to pain"; There are also definitions for situations in which fear of movement is most extreme or pain-related fear avoidance beliefs. Kinesiophobia, which usually occurs in the preoperative period and supports the development of chronic pain, may also affect the early recovery findings. It is very important to determine the presence and severity of kinesiophobia as it is associated with functional results after surgery.
Individuals' perceptions about themselves, expectations of recovery, and personal beliefs before surgery are thought to affect recovery in the early period. In the studies conducted, it was stated that individuals with high perception about himself and the surgical process recover faster and return to activities. However, it is emphasized that studies should be conducted on the effect of individuals' personal factors such as self-efficacy, self-perception and their perspective on health on the healing process.
Read the detailed description
Osteoarthritis, which is encountered more and more with the aging population; It can occur depending on various factors such as gender, age, genetic factors, type of nutrition and joint structure. According to the studies, osteortritis ranks eleventh in the world among the factors that cause disability in individuals. Self-care activities of osteortritis individuals, especially in walking and mobility restrictions, also limit the participation of producers and leisure activities. Pain is among the most important findings that cause limitation in participation for osteoarthritis, which is frequently seen in individuals over the age of 40. In individuals with osteoarthritis, methods such as the use of non-steroidal anti-inflammatory drugs and physical rehabilitation in coping with pain are frequently used in cases where these methods are insufficient.
Total knee arthroplasty (TDA) is a surgical approach that is frequently applied to reduce pain due to severe joint damage to the knee, improve functionality and quality of life. In our country, approximately 20 thousand knee arthroplasty surgeries are performed every year and individuals who have undergone this surgery are frequently among individuals over 60 years old. This surgery is usually performed in cases of pain, deformity or severe dysfunction resulting from arthritis (osteoarthritis, rheumatoid arthritis, other). Osteoarthritis is seen as one of the main causes of this practice.
Factors such as decreased pain, increased quality of life, increased functionality and decreased level of dependence on others are among the expectations for recovery from patients after surgery. Studies show that individuals can return to daily activities for the first six weeks after surgery, and pain-related symptoms decrease in the first four weeks and therefore functional recovery is accelerated. It is stated that full recovery includes a one-year period. However, among the reasons that negatively affect post-surgical healing, various conditions ranging from systemic problems to mortality, complications due to the healing of wounds, circulatory problems, motor losses due to peroneal nerve damage, impaired biomechanics of the knee joint, development of infection, relaxation of arthroplasty, dislocations and post-surgical idiopathic pain. development of physical factors.
It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Although kinesiophobia is defined as the terms of "fear of movement" and "fear related to pain"; There are also definitions for situations in which fear of movement is most extreme or pain-related fear avoidance beliefs. Kinesiophobia, which usually occurs in the preoperative period and supports the development of chronic pain, may also affect the early recovery findings. It is very important to determine the presence and severity of kinesiophobia as it is associated with functional results after surgery.
Individuals' perceptions about themselves, expectations of recovery, and personal beliefs before surgery are thought to affect recovery in the early period. In the studies conducted, it was stated that individuals with high perception about himself and the surgical process recover faster and return to activities. However, it is emphasized that studies should be conducted on the effect of individuals' personal factors such as self-efficacy, self-perception and their perspective on health on the healing process.
Investigation of factors affecting functional capacity, balance and mobility in individuals who have undergone total knee surgery with these approaches; Taking into account the perceptual problems that exist in addition to orthopedic problems, all problems in education are addressed holistically. Our work based on this idea; It is planned to investigate the factors affecting functional capacity, balance and mobility in individuals who have undergone total knee arthroplasty surgery.
In our study, between February 2020 and March 2020, Fırat University Training and Research Hospital, an orthopedic specialist will be diagnosed with osteoarthritis and patients who will undergo total knee arthroplasty surgery will be evaluated. Factors affecting patients' functional capacity, balance and mobility will be investigated.
From the patient records, as demographic features; patients' age, gender, body weight, height, hand (dominant hemisphere), profession and educational status, history of the disease will be taken. To our orthopedic evaluation form; muscle strength, range of motion, gait analysis, kinesiophobia, pain state, contracture state, obesity state, condition of intracapsular structures, etc. Information about will be obtained.
With these data, it will be investigated whether there is a change in the functional capacity, balance and mobility of patients, and which factors its balance depends on.
Individuals will be obtained from the individuals before surgery, 1 month after surgery and 3 months after surgery: TAMPA Kinesiophobia Scale, Lequesne knee osteoarthritis severity index, WOMAC scale and gait analysis evaluation data.
Statistical analysis of the study will be made with "Statistical Package for Social Sciences" (SPSS) Version IBM Statistic 20. Demographic data will be given as mean ± SD. Students t test will be used in continuous variables analysis, and Chi Square Test will be used to compare percentages. Differences below P value <0.05 will be considered meaningful.
- Conditions
- Kinesiophobia, Knee Osteoarthritis, Quality of Life
- Being tested
- No intervention will be made.
- Keywords
- knee arthroplasty, kinesiophobia, spatio-temporal, knee osteoarthritis, functionality
- Medical subject headings
- Kinesiophobia, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be made.Other
No intervention will be made. Only checks will be made
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals will be evaluated before knee arthroplasty surgery. They will come for control in the 1st and 3rd months after surgery.
No intervention will be made. Receives: Other: No intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Tampa Scale of Kinesiophobia
Evaluation will be done before surgery .Individuals' kinesiophobia will be evaluated
Measured: 2 weeks
The Tampa Scale of Kinesiophobia
Evaluation will be done before surgery at the 1st month.Individuals' kinesiophobia will be evaluated
Measured: 1 mounth
The Tampa Scale of Kinesiophobia
Evaluation will be done before surgery at the 3st month. Individuals' kinesiophobia will be evaluated
Measured: 3 Mounth
Secondary outcomes (12)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Evaluation will be done before surgery, Pain, joint stiffness and function data will be evaluated.
Measured: 2 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Evaluation will be done before surgery, at the 1st months. Pain, joint stiffness and function data will be evaluated.
Measured: 1 mounth
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Evaluation will be done before surgery, at the 3rd months. Pain, joint stiffness and function data will be evaluated.
Measured: 3 mounth
Spatio-temporal gait
Evaluation will be done before surgery. The data will be made with the Win-Track walking platform.
Measured: 2 weeks
Spatio-temporal gait
Evaluation will be done before surgery, at the 1st. The data will be made with the Win-Track walking platform.
Measured: 1 mounth
Spatio-temporal gait
Evaluation will be done before surgery, at the 3rd months. The data will be made with the Win-Track walking platform.
Measured: 3 mounth
Lequesne Index
Evaluation will be done before surgery. It is a 10-item scale consisting of 3 sections: pain / discomfort, daily life activities and maximum walking distance.
Measured: 2 weeks
Lequesne Index
Evaluation will be done before surgery, at the 1st. It is a 10-item scale consisting of 3 sections: pain / discomfort, daily life activities and maximum walking distance.
Measured: 1 mounth
Lequesne Index
Evaluation will be done before surgery, at the 3rd months. It is a 10-item scale consisting of 3 sections: pain / discomfort, daily life activities and maximum walking distance.
Measured: 3 mounth
Hormone level of iris
Evaluation will be done before surgery.Blood samples will be taken into gel biochemistry tubes, as appropriate for analysis from patients. The blood collected will be centrifuged for 10 minutes at 3000 rpm and the serum will be separated and the obtained serums will be placed in ependorphic tubes in small portions and stored at -80 ° C until analysis. The levels of iris will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits.
Measured: 2 weeks
Hormone level of iris
Evaluation will be done before surgery, at the 1st. Blood samples will be taken into gel biochemistry tubes, as appropriate for analysis from patients. The blood collected will be centrifuged for 10 minutes at 3000 rpm and the serum will be separated and the obtained serums will be placed in ependorphic tubes in small portions and stored at -80 ° C until analysis. The levels of iris will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits.
Measured: 1 Mounth
Hormone level of iris
Evaluation will be done before surgery, at the 3rd months. Blood samples will be taken into gel biochemistry tubes, as appropriate for analysis from patients. The blood collected will be centrifuged for 10 minutes at 3000 rpm and the serum will be separated and the obtained serums will be placed in ependorphic tubes in small portions and stored at -80 ° C until analysis. The levels of iris will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits.
Measured: 3 Mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Feb 2020
- Primary completion15 Mar 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314102
- Sponsor's protocol ID
- FiratUni
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palazzo C, Nguyen C, Lefevre-Colau MM, Rannou F, Poiraudeau S. Risk factors and burden of osteoarthritis. Ann Phys Rehabil Med. 2016 Jun;59(3):134-138. doi: 10.1016/j.rehab.2016.01.006. Epub 2016 Feb 19.
PubMed 26904959Başkurt Z, Ercan S, Parpucu Tİ, Başkurt F, Ünal M. Diz Osteoartriti Olan Hastalarda Kinezyobant Uygulamasının Kısa Dönem Etkileri. Spor Hekimliği Dergisi. 2017;52(4):146-54.
Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
PubMed 20418016Grayson CW, Decker RC. Total joint arthroplasty for persons with osteoarthritis. PM R. 2012 May;4(5 Suppl):S97-103. doi: 10.1016/j.pmrj.2012.02.018.
PubMed 22632709Ekşioğlu E, Gürçay E. Total diz artroplastisi sonrasi rehabilitasyon. İstanbul Tıp Fakültesi Dergisi. 2014;76(1):16-21.
Alsancak S, Altinkaynak H, Güner S. Sosyal Güvenlik Kurumu verilerine göre Türkiye'de hastaya özel yapılarak uygulanan profitez ve ortezlerin sayısal çeşitlilik analizi. Fizyoterapi Rehabilitasyon
Lotke PA. Primary Total Knee: Standard Principles and Technique In: Murphy RAHaD, editor. Knee Arthroplasty Lippincott Williams & Wilkins, a Wolters Kluwer business 2009.
Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.
PubMed 16108583Demir H, Çalış M. Diz artroplastisi rehabilitasyonu. Erciyes Medical Journal. 2002;24(4):194-201.
Aktuğ BB. Total diz artroplastili hastaların fonksiyonel düzeyleri ile memnuniyet düzeyleri arasındaki ilişkinin incelenmesi: DEÜ Sağlık Bilimleri Enstitüsü; 2009.
Morrey BF, Adams RA, Ilstrup DM, Bryan RS. Complications and mortality associated with bilateral or unilateral total knee arthroplasty. J Bone Joint Surg Am. 1987 Apr;69(4):484-8.
PubMed 3571305Peersman G, Laskin R, Davis J, Peterson MG, Richart T. Prolonged operative time correlates with increased infection rate after total knee arthroplasty. HSS J. 2006 Feb;2(1):70-2. doi: 10.1007/s11420-005-0130-2.
PubMed 18751850Geiger M, editor The Influence Of Psychological Factors On Reducing Recovery Time From Total Knee Replacement Surgery. Symposium; 2015. 45
Guney-Deniz H, Irem Kinikli G, Caglar O, Atilla B, Yuksel I. Does kinesiophobia affect the early functional outcomes following total knee arthroplasty? Physiother Theory Pract. 2017 Jun;33(6):448-453. doi: 10.1080/09593985.2017.1318988. Epub 2017 May 8.
PubMed 28481125Kocic M, Stankovic A, Lazovic M, Dimitrijevic L, Stankovic I, Spalevic M, Stojiljkovic P, Milenkovic M, Stojanovic Z, Nikolic D. Influence of fear of movement on total knee arthroplasty outcome. Ann Ital Chir. 2015 Mar-Apr;86(2):148-55.
PubMed 25952608
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiophobia on Spatio-temporal and Functionality in Individuals Who Have Undergone Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT04314102
- Acronym / sponsor ID
- FiratUni
- Conditions
- Kinesiophobia, Knee Osteoarthritis, Quality of Life
- Keywords
- knee arthroplasty, kinesiophobia, spatio-temporal, knee osteoarthritis, functionality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 18 Mar 2020 (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.
It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Although kinesiophobia is defined as the terms of "fear of movement" and "fear related to pain"; There are also definitions for situations in which fear of movement is most extreme or pain-related fear avoidance beliefs. Kinesiophobia, which usually occurs in the preoperative period and supports the development of chronic pain, may also affect the early recovery findings. It is very important to determine the presence and severity of kinesiophobia as it is associated with functional results after surgery.
Individuals' perceptions about themselves, expectations of recovery, and personal beliefs before surgery are thought to affect recovery in the early period. In the studies conducted, it was stated that individuals with high perception about himself and the surgical process recover faster and return to activities. However, it is emphasized that studies should be conducted on the effect of individuals' personal factors such as self-efficacy, self-perception and their perspective on health on the healing process.
Detailed description
Osteoarthritis, which is encountered more and more with the aging population; It can occur depending on various factors such as gender, age, genetic factors, type of nutrition and joint structure. According to the studies, osteortritis ranks eleventh in the world among the factors that cause disability in individuals. Self-care activities of osteortritis individuals, especially in walking and mobility restrictions, also limit the participation of producers and leisure activities. Pain is among the most important findings that cause limitation in participation for osteoarthritis, which is frequently seen in individuals over the age of 40. In individuals with osteoarthritis, methods such as the use of non-steroidal anti-inflammatory drugs and physical rehabilitation in coping with pain are frequently used in cases where these methods are insufficient.
Total knee arthroplasty (TDA) is a surgical approach that is frequently applied to reduce pain due to severe joint damage to the knee, improve functionality and quality of life. In our country, approximately 20 thousand knee arthroplasty surgeries are performed every year and individuals who have undergone this surgery are frequently among individuals over 60 years old. This surgery is usually performed in cases of pain, deformity or severe dysfunction resulting from arthritis (osteoarthritis, rheumatoid arthritis, other). Osteoarthritis is seen as one of the main causes of this practice.
Factors such as decreased pain, increased quality of life, increased functionality and decreased level of dependence on others are among the expectations for recovery from patients after surgery. Studies show that individuals can return to daily activities for the first six weeks after surgery, and pain-related symptoms decrease in the first four weeks and therefore functional recovery is accelerated. It is stated that full recovery includes a one-year period. However, among the reasons that negatively affect post-surgical healing, various conditions ranging from systemic problems to mortality, complications due to the healing of wounds, circulatory problems, motor losses due to peroneal nerve damage, impaired biomechanics of the knee joint, development of infection, relaxation of arthroplasty, dislocations and post-surgical idiopathic pain. development of physical factors.
It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Although kinesiophobia is defined as the terms of "fear of movement" and "fear related to pain"; There are also definitions for situations in which fear of movement is most extreme or pain-related fear avoidance beliefs. Kinesiophobia, which usually occurs in the preoperative period and supports the development of chronic pain, may also affect the early recovery findings. It is very important to determine the presence and severity of kinesiophobia as it is associated with functional results after surgery.
Individuals' perceptions about themselves, expectations of recovery, and personal beliefs before surgery are thought to affect recovery in the early period. In the studies conducted, it was stated that individuals with high perception about himself and the surgical process recover faster and return to activities. However, it is emphasized that studies should be conducted on the effect of individuals' personal factors such as self-efficacy, self-perception and their perspective on health on the healing process.
Investigation of factors affecting functional capacity, balance and mobility in individuals who have undergone total knee surgery with these approaches; Taking into account the perceptual problems that exist in addition to orthopedic problems, all problems in education are addressed holistically. Our work based on this idea; It is planned to investigate the factors affecting functional capacity, balance and mobility in individuals who have undergone total knee arthroplasty surgery.
In our study, between February 2020 and March 2020, Fırat University Training and Research Hospital, an orthopedic specialist will be diagnosed with osteoarthritis and patients who will undergo total knee arthroplasty surgery will be evaluated. Factors affecting patients' functional capacity, balance and mobility will be investigated.
From the patient records, as demographic features; patients' age, gender, body weight, height, hand (dominant hemisphere), profession and educational status, history of the disease will be taken. To our orthopedic evaluation form; muscle strength, range of motion, gait analysis, kinesiophobia, pain state, contracture state, obesity state, condition of intracapsular structures, etc. Information about will be obtained.
With these data, it will be investigated whether there is a change in the functional capacity, balance and mobility of patients, and which factors its balance depends on.
Individuals will be obtained from the individuals before surgery, 1 month after surgery and 3 months after surgery: TAMPA Kinesiophobia Scale, Lequesne knee osteoarthritis severity index, WOMAC scale and gait analysis evaluation data.
Statistical analysis of the study will be made with "Statistical Package for Social Sciences" (SPSS) Version IBM Statistic 20. Demographic data will be given as mean ± SD. Students t test will be used in continuous variables analysis, and Chi Square Test will be used to compare percentages. Differences below P value <0.05 will be considered meaningful.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No intervention will be made.Individuals will be evaluated before knee arthroplasty surgery. They will come for control in the 1st and 3rd months after surgery. No intervention will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with arthroplasty recommended for knee osteoarthritis
Key inclusion criteria (3 listed)
Key exclusion criteria (9 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be made.No intervention will be made. Only checks will be made | Other | 1 |
Primary outcome
The Tampa Scale of Kinesiophobia
Time frame: 2 weeks
Evaluation will be done before surgery .Individuals' kinesiophobia will be evaluated
The Tampa Scale of Kinesiophobia
Time frame: 1 mounth
Evaluation will be done before surgery at the 1st month.Individuals' kinesiophobia will be evaluated
The Tampa Scale of Kinesiophobia
Time frame: 3 Mounth
Evaluation will be done before surgery at the 3st month. Individuals' kinesiophobia will be evaluated
12 secondary outcomes
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 2 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 1 mounth
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3 mounth
Spatio-temporal gait
Time frame: 2 weeks
Spatio-temporal gait
Time frame: 1 mounth
Spatio-temporal gait
Time frame: 3 mounth
Lequesne Index
Time frame: 2 weeks
Lequesne Index
Time frame: 1 mounth
Lequesne Index
Time frame: 3 mounth
Hormone level of iris
Time frame: 2 weeks
Hormone level of iris
Time frame: 1 Mounth
Hormone level of iris
Time frame: 3 Mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 26904959Palazzo C, Nguyen C, Lefevre-Colau MM, Rannou F, Poiraudeau S. Risk factors and burden of osteoarthritis. Ann Phys Rehabil Med. 2016 Jun;59(3):134-138. doi: 10.1016/j.rehab.2016.01.006. Epub 2016 Feb 19.
- BackgroundBaşkurt Z, Ercan S, Parpucu Tİ, Başkurt F, Ünal M. Diz Osteoartriti Olan Hastalarda Kinezyobant Uygulamasının Kısa Dönem Etkileri. Spor Hekimliği Dergisi. 2017;52(4):146-54.
- Background: PubMed 20418016Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
- Background: PubMed 22632709Grayson CW, Decker RC. Total joint arthroplasty for persons with osteoarthritis. PM R. 2012 May;4(5 Suppl):S97-103. doi: 10.1016/j.pmrj.2012.02.018.
- BackgroundEkşioğlu E, Gürçay E. Total diz artroplastisi sonrasi rehabilitasyon. İstanbul Tıp Fakültesi Dergisi. 2014;76(1):16-21.
- BackgroundAlsancak S, Altinkaynak H, Güner S. Sosyal Güvenlik Kurumu verilerine göre Türkiye'de hastaya özel yapılarak uygulanan profitez ve ortezlerin sayısal çeşitlilik analizi. Fizyoterapi Rehabilitasyon
- BackgroundLotke PA. Primary Total Knee: Standard Principles and Technique In: Murphy RAHaD, editor. Knee Arthroplasty Lippincott Williams & Wilkins, a Wolters Kluwer business 2009.
- Background: PubMed 16108583Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.
- BackgroundDemir H, Çalış M. Diz artroplastisi rehabilitasyonu. Erciyes Medical Journal. 2002;24(4):194-201.
- BackgroundAktuğ BB. Total diz artroplastili hastaların fonksiyonel düzeyleri ile memnuniyet düzeyleri arasındaki ilişkinin incelenmesi: DEÜ Sağlık Bilimleri Enstitüsü; 2009.
- Background: PubMed 3571305Morrey BF, Adams RA, Ilstrup DM, Bryan RS. Complications and mortality associated with bilateral or unilateral total knee arthroplasty. J Bone Joint Surg Am. 1987 Apr;69(4):484-8.
- Background: PubMed 18751850Peersman G, Laskin R, Davis J, Peterson MG, Richart T. Prolonged operative time correlates with increased infection rate after total knee arthroplasty. HSS J. 2006 Feb;2(1):70-2. doi: 10.1007/s11420-005-0130-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinesiophobia and Knee Osteoarthritis, run by Firat University 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 3 inclusion and 9 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 18 Mar 2020. 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?
Results are not available in the source record.
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?
The Tampa Scale of Kinesiophobia (time frame: 2 weeks). 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?
On the ClinicalTrials.gov record for NCT04314102, which also lists 17 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 18 Mar 2020; AzTrials last refreshed its copy on 4 Nov 2026.