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The main purpose of this study is to evaluate whether recruitment rates are adequate to power a future RCT. The secondary aims are to obtain preliminary information about safety and efficacy of topical diphenhydramine 5% ointment in patients with knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diphenhydramine | Experimental | Topical 5% diphenhydramine ointment applied at knee joint at a dose of 2 g three times a day for 7 days |
|
| Placebo | Placebo Comparator | Vehicle (placebo) ointment applied at knee joint at a dose of 2 g three times a day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphenhydramine 5% | Drug | Diphenhydramine 5% ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rates | Ability to recruit 8 patients per month | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Refusal rate | Number of eligible patients who refuse to participate | through study completion, an average of 1 year |
| Adherence | Number of patients adhering to 80% of allocated treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Shirinsky, MD, Doctor of Science | Contact | +73832282547 | ivan.shirinsky@gmail.com | |
| Valery Shirinsky, Professor, MD | Contact | +73832282547 | valery.shirinsky@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Clinical Immunopharmacology | Novosibirsk | 630047 | Russia |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo |
| Drug |
Placebo matched to diphenhydramine 5% ointment |
|
| through study completion, an average of 1 year |
| Visual Analogue Scale for Pain | The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes. | Baseline to week 1 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain | KOOS Pain consists of 9 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.. | Baseline to week 1 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms | KOOS Symptoms consists of 7 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline to week 1 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) | KOOS ADL consists of 17 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline to week 1 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec) | KOOS Sport/Rec consists of 5 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline to week 1 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL) | KOOS QOL subscale of quality of life consists of 4 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline to week 1 |
| Visual Analogue Scale for patient global assessment | The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes. | Baseline to week 1 |
| Global evaluation of treatment by patient | Global evaluation of treatment by patient on 5 point Likert scale. The Global Evaluation of treatment varies from 0 to 5. Higher values represent worse outcomes. | Baseline to week 1 |
| Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain | Percentage of patients achieving MCII of VAS pain. The cut-off for MCII changes will be 15 of 100 for absolute improvement and 20% for relative improvement | Week 1 |
| Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment | Percentage of patients achieving MCII of VAS patient's global assessment The cut-offs for MCII changes will be 15 of 100 for absolute improvement and 20% for relative improvement for patient's global assessment | Week 1 |
| Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living | Percentage of patients achieving MCII of Knee injury and Osteoarthritis Outcome Score (KOOS) subscale of function of daily living. The cut-offs for MCII changes will be 8 of 100 for absolute improvement for KOOS function in daily living subscale score | Week 1 |
| Adverse events | Any adverse event occurred during the study | Baseline to Week 1 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |