Hand Osteoarthritis
Conditions
Keywords
hand osteoarthritis, osteoarthritis, arthritis, topical, multiprofen
Brief summary
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: * Use both Multiprofen-CC and a placebo (a cream with no active medicine) during the study, in a random order. * Be asked to apply 1 gram of cream to their hands three times a day for 2 weeks, following the manufacturer's instructions. * Attend a visit before starting the study, after 2 weeks, and after 6 weeks. * Report any symptoms they experience during the study.
Interventions
Standard care pain medications and topical Multiprofen-CC™ (1g TID) for 2 weeks
Standard care pain medications and visually identical topical placebo (1g TID) for 2 weeks
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
2x2 crossover randomized placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18+) * Have been diagnosed with hand osteoarthritis according to American College of Rheumatology criteria * Experience pain and/or loss of function in one or both hands that interferes with daily life * Provide informed consent
Exclusion criteria
* Unable to consent * Unable or unwilling to follow study protocol * Known allergy or contraindication to any of the study drugs or their ingredients * Have open wounds/cuts and/or skin conditions on the hand area * Pregnant or breastfeeding * History of impaired kidney or liver function * Rheumatoid or other inflammatory arthropathy * Hand surgery within the past 6 months or planned within the study period. * Use daily opioids (other than short acting codeine) for a chronic pain condition other than hand arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | baseline [week 0] and weeks 2, 4, and 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand function | weeks 2, 4 and 6 | 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. |
| Patients reported improvement | weeks 2, 4 and 6 | 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. |
| Safety - adverse events | through study completion, an average of 6 weeks | Hand-related and medication-related serious and non-serious adverse events |
Countries
Canada
Contacts
CONTACTBreanne Flood, MSc
CONTACTKim Irish, BSW
PRINCIPAL_INVESTIGATORCarolyn Levis, MD, MSc, FRCS(C)
McMaster University
Outcome results
None listed