Multiprofen-CC to Reduce Pain in Hand Arthritis
ConditionHand Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Multiprofen-CC™ plus standard treatment
DrugStandard care pain medications and topical Multiprofen-CC™ (1g TID) for 2 weeks
Placebo plus standard treatment
Other interventionStandard care pain medications and visually identical topical placebo (1g TID) for 2 weeks
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Multiprofen-CC™Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline [week 0] and weeks 2, 4, and 6Secondary outcomes
1
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.
Time frame
weeks 2, 4 and 62
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.
Time frame
weeks 2, 4 and 63
Safety - adverse events
Hand-related and medication-related serious and non-serious adverse events
Time frame
through study completion, an average of 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov