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The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981
The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expermental group 1 | Experimental | Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo. |
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| Expermental group 2 | Experimental | Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo. |
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| Sham group | Sham Comparator | Patients assigned to this group will receive treatment with the sham device in combination with a placebo. |
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| Reference group | Sham Comparator | Patients assigned to this group will receive treatment with the sham device in combination with a reference drug. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-981(1) | Device | 20 minutes per day, 5 days a week for 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS) | Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain) | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS) | Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain) | 2 weeks, 4 weeks |
| Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
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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 |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| CKD-981(2) | Device | 20 minutes per day, 5 days a week for 6 weeks. |
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| Sham device | Device | 20 minutes per day, 5 days a week for 6 weeks. |
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| Reference Drug | Drug | QD for 6 weeks |
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| Placebo Drug | Drug | QD for 6 weeks |
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The K-WOMAC consists of 24 items, with each item scored on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), where higher scores indicate greater symptom severity |
| 2 weeks, 4 weeks, 6 weeks |
| D012216 |
| Rheumatic Diseases |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |