- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07618403
Physical Therapy Program and Treatment Expectations in Knee Osteoarthritis
24. maj 2026 opdateret af: Levent Karataş, Gazi University
Evaluating The Predictive Effect of Treatment Expectations on Response to A Physical Therapy Program in Patients With Knee Osteoarthritis
To our knowledge, no studies have been conducted in the literature investigating the relationship between the success of physical therapy programs applied in knee osteoarthritis and patients' pre-treatment expectations.
The rationale for this study is to demonstrate the possible relationship between treatment expectations and the benefits seen from conventional physical therapy programs in patients with knee osteoarthritis, and to provide clinicians with a different perspective in knee osteoarthritis treatment planning.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
Osteoarthritis, also called degenerative joint disease, primarily occurs in old age, but can also develop after trauma or secondarily to diseases such as rheumatoid arthritis and hemochromatosis.
Osteoarthritis is the most common joint disease worldwide.
The pathophysiology of osteoarthritis is responsible for the failed repair of joint damage caused by stress initiated by any joint or periarticular tissue abnormality.
The most common symptom of osteoarthritis is pain.
Factors associated with an increased risk of knee osteoarthritis include advanced age, family history, overweight or obesity, a history of knee trauma, occupational factors, and varus or valgus alignment.
Long-term complications of osteoarthritis include decreased physical activity, loss of fitness, sleep disturbances, fatigue, and depression.
With the increasing aging population, degenerative joint problems have become a concern for a large part of society.
Exercise is a key component in the treatment of this chronic disease, which restricts functionality and reduces quality of life.
A systematic review of 54 randomized controlled trials involving a total of 5362 participants showed that different types of exercise improved pain, functionality, and quality of life in knee osteoarthritis.
Studies have shown that treatment outcomes are not always similar in patients undergoing similar treatment programs, and that patients' expectations from treatment can also influence results.
A systematic literature review on improvement expectations revealed that in 15 out of 16 studies, positive patient expectations were associated with better health outcomes.
A recent study in the field of physical therapy also showed that in the treatment of chronic low back pain, high patient expectations were associated with the success of the treatment.
Therefore, we planned this study to answer the questions of whether treatment expectations have a predictive effect on the benefits seen from an exercise program in patients with knee osteoarthritis, and whether it is necessary to evaluate the level of expectations when creating a treatment program for patients with knee osteoarthritis.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
84
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Burak Tokac
- Telefonnummer: +905313474837
- E-mail: buraktokac96@gmail.com
Undersøgelse Kontakt Backup
- Navn: Levent Karatas
- Telefonnummer: +9005055629437
Studiesteder
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Yenimahalle
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Ankara, Yenimahalle, Tyrkiet (Türkiye), 06170
- Rekruttering
- Gazi University
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Kontakt:
- Levent Karatas, Doc
- Telefonnummer: +90 505 562 94 37
- E-mail: dr.levent.karatas@gmail.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients aged 50 years and older who present with knee pain and are found to have grade 2 or higher gonarthrosis according to the Kellgren-Lawrence classification on X-ray imaging.
Beskrivelse
Inclusion Criteria:
- Agreeing to participate in the study
- Being over 50 years of age
- Having a clinically and radiographically confirmed diagnosis of knee osteoarthritis
- Having grade 2-3-4 knee osteoarthritis according to the Kellgren-Lawrence grading system
- Being literate
Exclusion Criteria:
- Previous knee surgery
- Conditions that prevent exercise (such as incurable malignancy, active systemic infection, non-union fracture)
- Presence of accompanying neurological disease affecting the lower extremity
- Severe cognitive impairment (neuropsychiatric disease or condition that will impede cooperation, such as psychosis, dementia)
- History of having received injections or other procedures to the knee joint or physical therapy within the last 6 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Those with Low Treatment Expectations
|
Patients in both groups will receive 15 sessions of a conventional physical therapy program.
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Those with High Treatment Expectations
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Patients in both groups will receive 15 sessions of a conventional physical therapy program.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Tidsramme: From enrollment day to the end of the rehabilitation program at 4 weeks
|
WOMAC score evaluation following the last treatment session.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis.
It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items).
Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations.
The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.
|
From enrollment day to the end of the rehabilitation program at 4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Smerteniveau; VAS score
Tidsramme: Fra indskrivningsdag til afslutning af rehabiliteringsprogrammet ved 4 uger
|
Visual Analog Scale (VAS) er et værktøj, der bruges til at måle en patients smerteniveau.
Den består af en lige linje med endepunkter, der definerer ekstreme grænser såsom 'ingen smerte' og 'værst tænkelige smerte'.
Patienten markerer på linjen det punkt, som de føler repræsenterer deres opfattelse af deres nuværende tilstand.
Denne metode er enkel, pålidelig og udbredt i både kliniske og forskningsmæssige omgivelser til at kvantificere smerteintensiteten.
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Fra indskrivningsdag til afslutning af rehabiliteringsprogrammet ved 4 uger
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Timed Up and Go Test (TUG)
Tidsramme: From enrollment day to the end of the rehabilitation program at 4 weeks
|
A rapid, standardized clinical tool used to measure a person's functional mobility, dynamic balance, and fall risk.
It measures the time it takes for a person to get up from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down again.
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From enrollment day to the end of the rehabilitation program at 4 weeks
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Stair Climbing Test (SCT)
Tidsramme: From enrollment day to the end of the rehabilitation program at 4 weeks
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The stair climbing test assesses lower body strength, functional capacity, and cardiopulmonary fitness by measuring how quickly you can safely climb and descend a flight of stairs.
Versions are available with 3 to 12 steps; this study will use the 12-step version.
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From enrollment day to the end of the rehabilitation program at 4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Levent Karatas, Gazi University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
- Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- Myers SS, Phillips RS, Davis RB, Cherkin DC, Legedza A, Kaptchuk TJ, Hrbek A, Buring JE, Post D, Connelly MT, Eisenberg DM. Patient expectations as predictors of outcome in patients with acute low back pain. J Gen Intern Med. 2008 Feb;23(2):148-53. doi: 10.1007/s11606-007-0460-5. Epub 2007 Dec 8.
- Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.
- Mondloch MV, Cole DC, Frank JW. Does how you do depend on how you think you'll do? A systematic review of the evidence for a relation between patients' recovery expectations and health outcomes. CMAJ. 2001 Jul 24;165(2):174-9.
- Levenig CG, Hasenbring MI, Gunnewig L, Titze C, Elsenbruch S, Schulte TL. Treatment Expectations-You Get What You Expect-and Depression Plays a Role. J Pain. 2024 Sep;25(9):104582. doi: 10.1016/j.jpain.2024.104582. Epub 2024 May 29.
- Robinson ME, Brown JL, George SZ, Edwards PS, Atchison JW, Hirsh AT, Waxenberg LB, Wittmer V, Fillingim RB. Multidimensional success criteria and expectations for treatment of chronic pain: the patient perspective. Pain Med. 2005 Sep-Oct;6(5):336-45. doi: 10.1111/j.1526-4637.2005.00059.x.
- Abdel-Aziz MA, Ahmed HMS, El-Nekeety AA, Abdel-Wahhab MA. Osteoarthritis complications and the recent therapeutic approaches. Inflammopharmacology. 2021 Dec;29(6):1653-1667. doi: 10.1007/s10787-021-00888-7. Epub 2021 Nov 9.
- Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2026
Primær færdiggørelse (Anslået)
1. september 2027
Studieafslutning (Anslået)
15. september 2027
Datoer for studieregistrering
Først indsendt
24. maj 2026
Først indsendt, der opfyldte QC-kriterier
24. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. maj 2026
Sidst verificeret
1. maj 2026
Mere information
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