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Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain, functional outcomes, and health-related quality of life among adults with early-stage KOA. The results are intended to provide evidence on the optimal components of home-based conservative management strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Exercise Group | Experimental | Each subject in the home exercise group will receive a video-based protocol of exercises for knee osteoarthritis to perform at home. |
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| Topical Therapy Group | Active Comparator | Each subject in the topical therapy group will apply topical gel to anterior, medial, and lateral aspects of the knee at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Exercise Group | Other | Patient education + structured, video-based home exercise program Participants instructed to perform exercises 5 days per week for 6 weeks Adherence monitored via logs and telephone follow-up at week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2. | Baseline |
| Numeric Pain Rating Scale (NPRS) | Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2. | Six-week |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points. | Baseline |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpaşa Faculty of Health Science | Istanbul | Buyukcekmece | 34500 | Turkey (Türkiye) | ||
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized Controlled Trial
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single
| Topical Therapy Group | Other | Patient education + 1.5% diclofenac sodium gel Participants applied gel to anterior, medial, and lateral aspects of the knee, once daily, without massage techniques, for 6 weeks |
|
The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points. |
| Six-week |
| 12-Item Short Form Survey (SF-12) | The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life | Baseline |
| 12-Item Short Form Survey (SF-12) | The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life | Six- week |
| Sezen Karaborklu Argut |
| Istanbul |
| 34295 |
| Turkey (Türkiye) |
| D012216 |
| Rheumatic Diseases |