NCT04314102

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

March 13, 2020

Last Update Submit

March 17, 2020

Conditions

KinesiophobiaKnee OsteoarthritisQuality of Life

Keywords

knee arthroplastykinesiophobiaspatio-temporalknee osteoarthritisfunctionality

Outcome Measures

Primary Outcomes (3)

  • The Tampa Scale of Kinesiophobia

    Evaluation will be done before surgery .Individuals' kinesiophobia will be evaluated

    2 weeks

  • The Tampa Scale of Kinesiophobia

    Evaluation will be done before surgery at the 1st month.Individuals' kinesiophobia will be evaluated

    1 mounth

  • The Tampa Scale of Kinesiophobia

    Evaluation will be done before surgery at the 3st month. Individuals' kinesiophobia will be evaluated

    3 Mounth

Secondary Outcomes (12)

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    2 weeks

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    1 mounth

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    3 mounth

  • Spatio-temporal gait

    2 weeks

  • Spatio-temporal gait

    1 mounth

  • +7 more secondary outcomes

Study Arms (1)

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.

Other: No intervention will be made.

Interventions

No intervention will be made.OTHER

No intervention will be made. Only checks will be made

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with arthroplasty recommended for knee osteoarthritis

You may qualify if:

  • Between 30-90 years old,
  • Primary unilateral total knee replacement will be applied due to knee osteoarthritis,
  • Patients volunteering to participate in the study

You may not qualify if:

  • 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),
  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat Univerity Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (17)

  • 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.

    PMID: 26904959BACKGROUND

  • Başkurt 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

  • 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.

    PMID: 20418016BACKGROUND

  • Grayson 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.

    PMID: 22632709BACKGROUND

  • Ekşioğlu E, Gürçay E. Total diz artroplastisi sonrasi rehabilitasyon. İstanbul Tıp Fakültesi Dergisi. 2014;76(1):16-21.

    BACKGROUND

  • 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

    BACKGROUND

  • Lotke PA. Primary Total Knee: Standard Principles and Technique In: Murphy RAHaD, editor. Knee Arthroplasty Lippincott Williams & Wilkins, a Wolters Kluwer business 2009.

    BACKGROUND

  • 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.

    PMID: 16108583BACKGROUND

  • Demir H, Çalış M. Diz artroplastisi rehabilitasyonu. Erciyes Medical Journal. 2002;24(4):194-201.

    BACKGROUND

  • Aktuğ BB. Total diz artroplastili hastaların fonksiyonel düzeyleri ile memnuniyet düzeyleri arasındaki ilişkinin incelenmesi: DEÜ Sağlık Bilimleri Enstitüsü; 2009.

    BACKGROUND

  • 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.

    PMID: 3571305BACKGROUND

  • Peersman 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.

    PMID: 18751850BACKGROUND

  • Geiger M, editor The Influence Of Psychological Factors On Reducing Recovery Time From Total Knee Replacement Surgery. Symposium; 2015. 45

    BACKGROUND

  • 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.

    PMID: 28481125BACKGROUND

  • Kocic 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.

    PMID: 25952608BACKGROUND

  • Lundberg M. Kinesiophobia Various Aspects of Moving with Musculoskeletal Pain 2006.

    BACKGROUND

  • Hanusch BC, O'Connor DB, Ions P, Scott A, Gregg PJ. Effects of psychological distress and perceptions of illness on recovery from total knee replacement. Bone Joint J. 2014 Feb;96-B(2):210-6. doi: 10.1302/0301-620X.96B2.31136.

    PMID: 24493186BACKGROUND

MeSH Terms

Conditions

KinesiophobiaOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 18, 2020

Study Start

February 1, 2020

Primary Completion

March 15, 2020

Study Completion

May 15, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)