Multiprofen-CC to Reduce Pain in Hand Arthritis

Phase 3RecruitingNCT06966206

St. Joseph's Healthcare Hamilton42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hand Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 6

Secondary Outcomes

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 6

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 6

Safety - adverse events

Hand-related and medication-related serious and non-serious adverse events

Time frame: through study completion, an average of 6 weeks