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NCT Number: NCT07618403

Physical Therapy Program and Treatment Expectations in 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

Patients in both groups will receive 15 sessions of a conventional physical therapy program.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Tokac

CONTACT

[email protected]

+905313474837

Levent Karatas

CONTACT

+9005055629437

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Evaluating The Predictive Effect of Treatment Expectations on Response to A Physical Therapy Program in Patients With Knee Osteoarthritis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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