The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee. The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred. Hypothesis/Purpose * Pain scores after active treatment will be significantly reduced in comparison to placebo. * There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo. * There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6. * The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
CDHA - Pain Management Unit
Halifax, Nova Scotia, Canada
Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada
Change in mean daily pain diary score from baseline
The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.
Time frame: three weeks
WOMAC
The Western Ontario and McMaster Universities Arthritis Index is a well validated and widely used measure to assess pain, stiffness and physical function in individuals with OA of the knee or hip. It consists of 24 questions divided into 3 scales (pain, stiffness and physical function). This scale has been found to be sensitive to interventions used for osteoarthritis and is noted by IMMPACT as an example of an appropriate disease specific measure of physical function.
Time frame: Six weeks
BPI-SF
The BPI pain scale has been widely used and found to provide a reliable and valid measure of pain and pain's interference with physical functioning in seven areas including: general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. The instrument consists of a series of 11-point numeric rating scales asking the participant to rate the pain and indicate how much the pain has interfered with seven areas (0 indicating "does not interfere", 10 indicating "completely interferes").
Time frame: six weeks
PGIC
The Patient Global Impression of Change Scale (PGIC). This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved' to "very much worse" with "no-change, as the mid-point.
Time frame: six weeks
PGSS
The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.
Time frame: six weeks
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