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This clinical trial aims to find out if using 1 gram of Multiprofen-CC cream on the hands three times a day for 4 weeks can help reduce pain in adults with hand osteoarthritis, compared to a placebo (a cream with no active medicine). The research team will also look at how Multiprofen-CC affects hand function, opioid use, and how patients feel about their overall improvement. In addition, the research team will keep track of any side effects.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiprofen-CCâ„¢ | Experimental | Multiprofen-CCâ„¢ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 2 weeks |
|
| Placebo | Placebo Comparator | The placebo is the base cream with no medicinal ingredients Dose: 1.0g, 3 times per day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiprofen-CCâ„¢ plus standard treatment | Drug | Standard care pain medications and topical Multiprofen-CCâ„¢ (1g TID) for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Average pain intensity will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Scores are collected before and after each treatment period. Higher scores indicate greater pain intensity and thus a worse outcome. | baseline [week 0] and weeks 2, 4, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand function | Measured using the Michigan Hand Outcomes Questionnaire (MHQ), a validated instrument assessing hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. The total score ranges from 0 to 100, with higher scores representing better overall hand function and patient-reported outcomes. | weeks 2, 4 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Breanne Flood, MSc | Contact | 905-870-1382 | bflood@stjoes.ca | |
| Kim Irish, BSW | Contact | 365-336-7598 | irishkd@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Levis, MD, MSc, FRCS(C) | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N4A6 | Canada |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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2x2 crossover randomized placebo-controlled trial
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| Placebo plus standard treatment | Other | Standard care pain medications and visually identical topical placebo (1g TID) for 2 weeks |
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| Patients reported improvement | Measured using the Patient Global Impression of Change (PGIC) scale, a single-item, patient-reported measure of overall improvement. The scale ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse." Lower scores represent better outcomes. | weeks 2, 4 and 6 |
| Safety - adverse events | Hand-related and medication-related serious and non-serious adverse events | through study completion, an average of 6 weeks |