Osteoarthritis
Conditions
Keywords
osteoarthritis, knee, pain, antihistamines
Brief summary
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.
Interventions
DRUGDiphenhydramine 5%
Diphenhydramine 5% ointment
DRUGPlacebo
Placebo matched to diphenhydramine 5% ointment
Sponsors
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ACR clinical criteria of knee OA 2. Radiographic knee OA (Kellgren-Lawrence grade \>1) 3. Age ≥ 50 years 4. VAS pain \>= 40/100 mm at baseline 5. Non-use of NSAIDs one week before the baseline 6. Symptoms present on most days for at least 3 months
Exclusion criteria
1. Any form of inflammatory arthritis 2. Use of another topical product at the application site 3. Treatment with intraarticular hyaluronic acid within 6 months 4. Treatment with intraarticular glucocorticoid within 2 months 5. Knee injury/surgery or diagnostic arthroscopy within 3 months 6. Allergic reaction to diphenhydramine or any component of the formulation 7. Participant has clinical signs and symptoms suggestive of COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates | through study completion, an average of 1 year | Ability to recruit 8 patients per month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | through study completion, an average of 1 year | Number of patients adhering to 80% of allocated treatment |
| Visual Analogue Scale for Pain | Baseline to week 1 | The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain | Baseline to week 1 | 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.. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms | Baseline to week 1 | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) | Baseline to week 1 | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of function in sports and recreation (Sport/Rec) | Baseline to week 1 | 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. |
| Refusal rate | through study completion, an average of 1 year | Number of eligible patients who refuse to participate |
| Visual Analogue Scale for patient global assessment | Baseline to week 1 | The Visual Analogue Scale for patient global assessment varies from 0 to 10 cm. Higher values represent worse outcomes. |
| Global evaluation of treatment by patient | Baseline to week 1 | 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. |
| Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) pain | Week 1 | 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 |
| Percentage of patients achieving minimal clinically important improvement (MCII) of visual analogue scale (VAS) patient's global assessment | Week 1 | 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 |
| Percentage of patients achieving minimal clinically important improvement (MCII) of Knee injury and Osteoarthritis Outcome Score (KOOS) function of daily living | Week 1 | 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 |
| Adverse events | Baseline to Week 1 | Any adverse event occurred during the study |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale of quality of life (QOL) | Baseline to week 1 | 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. |
Countries
Russia
Contacts
Primary ContactIvan Shirinsky, MD, Doctor of Science
Backup ContactValery Shirinsky, Professor, MD
Outcome results
None listed