Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of adult patients aged 40 to 75 years with clinically and radiographically confirmed knee osteoarthritis according to the American College of Rheumatology (ACR) criteria and Kellgren-Lawrence grade II or III disease. Participants will be recruited consecutively from the outpatient Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital. All eligible patients who meet the inclusion criteria and provide written informed consent will receive a standardized physical therapy program and will be prospectively followed to evaluate the effect of alexithymia on treatment response.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard Physical Therapy Program

    Procedure/Surgery

    All participants will receive the same standardized physical therapy program consisting of: Transcutaneous Electrical Nerve Stimulation (TENS) for 20 minutes, Superficial heat therapy (hot pack) for 20 minutes, Therapeutic ultrasound (1 MHz, 1.5 W/cm²) for 5 minutes, A home exercise program targeting the muscles around the knee. The treatment will be administered 5 days per week for 3 weeks, for a total of 15 sessions.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Alexithymia-Positive Cohort1 intervention
Group B: Alexithymia-Negative Cohort1 intervention

Trial outcomes

Primary outcomes

1

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

The primary outcome is the change in the WOMAC total score, which assesses pain, stiffness, and physical function in patients with knee osteoarthritis.

Time frame
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.

Secondary outcomes

1

Change in Visual Analog Scale (VAS) Pain Score

Pain intensity will be assessed using the Visual Analog Scale (VAS), and the change from baseline after treatment will be evaluated.

Time frame
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
2

Change in Hospital Anxiety and Depression Scale (HADS) Score

Changes in anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS).

Time frame
Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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