Knee OsteoarthritisALEX-KOANCT07651410
Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Standard Physical Therapy Program
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Detailed Description
Knee osteoarthritis (KOA) is one of the most prevalent degenerative musculoskeletal disorders and represents a major cause of chronic pain, disability, and reduced quality of life worldwide. Although structural joint degeneration is a hallmark of the disease, increasing evidence suggests that psychological factors also contribute to pain perception, functional impairment, and variability in treatment outcomes.
Alexithymia is a personality construct characterized by difficulty in identifying, describing, and expressing emotions. Previous studies have demonstrated that alexithymia is associated with greater pain severity, poorer functional status, and unfavorable clinical outcomes in various chronic pain conditions. However, its influence on the response to conservative treatment in patients with knee osteoarthritis has not been adequately investigated.
The primary objective of this prospective observational cohort study is to evaluate whether alexithymia influences the clinical response to a standardized physical therapy program in patients with knee osteoarthritis. The secondary objective is to determine whether alexithymia independently predicts treatment outcomes after adjustment for potential confounding factors.
Patients aged 40 to 75 years with clinically and radiographically diagnosed knee osteoarthritis will be enrolled. All participants will receive a standardized physical therapy program consisting of Transcutaneous Electrical Nerve Stimulation (TENS), superficial heat therapy (hot pack), therapeutic ultrasound, and a home exercise program over a three-week treatment period.
Clinical evaluations will be performed at baseline, immediately after completion of treatment, and six weeks after treatment completion. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), alexithymia using the Toronto Alexithymia Scale-20 (TAS-20), and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Participants will be classified as alexithymia-positive or alexithymia-negative according to their baseline TAS-20 scores.
The primary outcome measure will be the change in WOMAC total score. Secondary outcome measures will include changes in VAS and HADS scores. Multivariable regression analyses will be performed to determine whether alexithymia is an independent predictor of response to physical therapy after adjustment for demographic and clinical variables.
- Conditions
- Knee Osteoarthritis
- Being tested
- Standard Physical Therapy Program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Physical Therapy ProgramProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pain intensity will be assessed using the Visual Analog Scale (VAS), and the change from baseline after treatment will be evaluated.
Measured: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
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).
Measured: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion25 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651410
- Sponsor's protocol ID
- KSUH-OA-ALEX-2026-01
- Acronym
- ALEX-KOA
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable, as Individual Participant Data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alexithymia on Response to Physical Therapy in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07651410
- Acronym / sponsor ID
- ALEX-KOA / KSUH-OA-ALEX-2026-01
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
Knee osteoarthritis (KOA) is one of the most prevalent degenerative musculoskeletal disorders and represents a major cause of chronic pain, disability, and reduced quality of life worldwide. Although structural joint degeneration is a hallmark of the disease, increasing evidence suggests that psychological factors also contribute to pain perception, functional impairment, and variability in treatment outcomes.
Alexithymia is a personality construct characterized by difficulty in identifying, describing, and expressing emotions. Previous studies have demonstrated that alexithymia is associated with greater pain severity, poorer functional status, and unfavorable clinical outcomes in various chronic pain conditions. However, its influence on the response to conservative treatment in patients with knee osteoarthritis has not been adequately investigated.
The primary objective of this prospective observational cohort study is to evaluate whether alexithymia influences the clinical response to a standardized physical therapy program in patients with knee osteoarthritis. The secondary objective is to determine whether alexithymia independently predicts treatment outcomes after adjustment for potential confounding factors.
Patients aged 40 to 75 years with clinically and radiographically diagnosed knee osteoarthritis will be enrolled. All participants will receive a standardized physical therapy program consisting of Transcutaneous Electrical Nerve Stimulation (TENS), superficial heat therapy (hot pack), therapeutic ultrasound, and a home exercise program over a three-week treatment period.
Clinical evaluations will be performed at baseline, immediately after completion of treatment, and six weeks after treatment completion. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), alexithymia using the Toronto Alexithymia Scale-20 (TAS-20), and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Participants will be classified as alexithymia-positive or alexithymia-negative according to their baseline TAS-20 scores.
The primary outcome measure will be the change in WOMAC total score. Secondary outcome measures will include changes in VAS and HADS scores. Multivariable regression analyses will be performed to determine whether alexithymia is an independent predictor of response to physical therapy after adjustment for demographic and clinical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alexithymia-Positive Cohort | – | Procedure: Standard Physical Therapy ProgramParticipants 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. |
| Alexithymia-Negative Cohort | – | Procedure: Standard Physical Therapy ProgramParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Physical Therapy ProgramAll 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. | Procedure or surgery | Alexithymia-Negative Cohort, Alexithymia-Positive Cohort |
Primary outcome
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
The primary outcome is the change in the WOMAC total score, which assesses pain, stiffness, and physical function in patients with knee osteoarthritis.
2 secondary outcomes
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Not applicable, as Individual Participant Data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Kanuni Sultan Suleyman Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Karakuzu Güngör, M.D (+90 212 404 15 00, zeynepkarakuzu@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score (time frame: Baseline, immediately after completion of treatment (3 weeks), and 6 weeks after completion of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.