- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618403
Physical Therapy Program and Treatment Expectations in Knee Osteoarthritis
May 24, 2026 updated by: 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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Burak Tokac
- Phone Number: +905313474837
- Email: buraktokac96@gmail.com
Study Contact Backup
- Name: Levent Karatas
- Phone Number: +9005055629437
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06170
- Recruiting
- Gazi University
-
Contact:
- Levent Karatas, Doc
- Phone Number: +90 505 562 94 37
- Email: dr.levent.karatas@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Those with Low Treatment Expectations
|
Patients in both groups will receive 15 sessions of a conventional physical therapy program.
|
|
Those with High Treatment Expectations
|
Patients in both groups will receive 15 sessions of a conventional physical therapy program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level; VAS score
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
|
The Visual Analog Scale (VAS) is a tool used to measure a patient's level of pain.
It consists of a straight line with endpoints defining extreme limits such as 'no pain' and 'worst pain imaginable.'
The patient marks on the line the point that they feel represents their perception of their current state.
This method is simple, reliable, and widely used in both clinical and research settings to quantify pain intensity.
|
From enrollment day to the end of the rehabilitation program at 4 weeks
|
|
Timed Up and Go Test (TUG)
Time Frame: 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.
|
From enrollment day to the end of the rehabilitation program at 4 weeks
|
|
Stair Climbing Test (SCT)
Time Frame: From enrollment day to the end of the rehabilitation program at 4 weeks
|
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.
|
From enrollment day to the end of the rehabilitation program at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Levent Karatas, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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/
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 15, 2027
Study Registration Dates
First Submitted
May 24, 2026
First Submitted That Met QC Criteria
May 24, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 24, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gonartroz -Tedavi Beklentisi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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