Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis (NCT07651410) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis
60 participantsStarted 2026-06-25
Plain-language summary
Knee osteoarthritis is one of the most common degenerative joint diseases and is associated with chronic pain, functional impairment, and reduced quality of life. Psychological factors may influence both symptom severity and response to treatment. Alexithymia, characterized by difficulty in identifying and expressing emotions, has been associated with poorer outcomes in chronic pain conditions.
The aim of this prospective observational study is to investigate whether the presence of alexithymia affects the clinical response to a standardized physical therapy program in patients with knee osteoarthritis. Participants will undergo a standard physical therapy regimen and will be evaluated before treatment, immediately after treatment, and 6 weeks after treatment completion. Pain, functional status, alexithymia, anxiety, and depression will be assessed using validated clinical scales. The study seeks to determine whether alexithymia is an independent predictor of treatment response in patients with knee osteoarthritis.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age between 40 and 75 years. Diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
Kellgren-Lawrence grade II or III on radiographic evaluation. Presence of symptomatic knee pain requiring physical therapy. Willingness and ability to participate in the standardized physical therapy program.
Ability to complete study questionnaires and clinical assessments. Provision of written informed consent prior to participation.
Exclusion Criteria:
Age younger than 40 years or older than 75 years. Kellgren-Lawrence grade I or grade IV knee osteoarthritis. Previous knee arthroplasty or major knee surgery on the affected side. Lower extremity surgery within the previous 6 months. Intra-articular corticosteroid, hyaluronic acid, platelet-rich plasma, prolotherapy, or stem cell injection into the knee within the previous 3 months.
Physical therapy for knee osteoarthritis within the previous 3 months. Acute knee trauma or fracture. Inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
Fibromyalgia or chronic widespread pain syndrome. Active infection or malignancy. Neurological disorders significantly affecting lower extremity function or balance (e.g., stroke, Parkinson's disease, multiple sclerosis).
Severe cognitive impairment or major psychiatric illness that may interfere with study participation or questionnaire completion.
Contraindications to physical therapy …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Timeframe: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Trial details
NCT IDNCT07651410
SponsorKanuni Sultan Suleyman Training and Research Hospital