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

NCT07651410 | Not Yet Recruiting

• 1 other identifier: KSUH-OA-ALEX-2026-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

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.

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

Secondary Outcomes (2)

• Change in Visual Analog Scale (VAS) Pain Score

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

• Change in Hospital Anxiety and Depression Scale (HADS) Score

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

Study Arms (2)

Alexithymia-Positive Cohort

Participants with knee osteoarthritis who have a Toronto Alexithymia Scale-20 (TAS-20) score of 61 or higher at baseline. All participants will receive the same standardized physical therapy program and will be followed prospectively to evaluate treatment response.

Procedure: Standard Physical Therapy Program

Alexithymia-Negative Cohort

Participants with knee osteoarthritis who have a Toronto Alexithymia Scale-20 (TAS-20) score of less than 61 at baseline. All participants will receive the same standardized physical therapy program and will be followed prospectively to evaluate treatment response.

Procedure: Standard Physical Therapy Program

Interventions

Standard Physical Therapy Program PROCEDURE

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.

Alexithymia-Negative Cohort; Alexithymia-Positive Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 modalities (TENS, therapeutic ultrasound, or superficial heat therapy).
• Regular opioid analgesic use or other medications that may substantially influence pain perception.
• Pregnancy or breastfeeding. Inability to comply with the treatment protocol or follow-up assessments. Participation in another interventional clinical study during the study period. Refusal or inability to provide written informed consent.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

+90 212 404 15 00; zeynepkarakuzu@hotmail.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share