Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Participants in either the active dose (7.5 grams of finely ground plant material per 100 ml of transdermal cream = 0.94% cannabinoid) and the placebo dose conditions will be asked to apply the cream
Sponsors
Medicinal Cannabis Resource Centre Inc (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females between the ages of 21 ? 75 with a diagnosis of rheumatoid arthritis of the proximal interphalangeal joints that is not adequately controlled by standard medication and remain symptomatic.
Exclusion criteria
Exclusion criteria: 1. A history of psychiatric disorders or substance misuse 2. Severe cardiovascular 3. Renal of hepatic disorder 4. A history of epilepsy 5. Recreational or medicinal use of cannabis within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint assessed will be daily pain experience as self-reported by the participants measured by a 0 ? 10 Numeric Rating Scale (NRS) 10 minutes following the application of the topical cream preparation (either active dose or placebo dose). The daily NRS rating will be then be averaged for measurements points obtained at midway through the 6 week clinical trial, at the end of the clinical trial and finally at 2 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include: 1. Assessment of functional status using scores on the Stanford Health Assessment Questionnaire (HAQ, full version, Fries, Spitz, Kraines & Holman, 1980). This is a self-administered, 41 item measure that contains 8 categories which review a specific function evaluating difficulty with activities of daily living (e.g., dressing, grooming, arising, eating, walking, hygiene, errands and chores) over the past week. Also identified are specific aids or devices utilized for assistance such as help needed from another person. 2. Assessment of self-reported activities of daily living and quality of life as measured by the Rheumatoid Arthritis Quality of Life (RAQL, De Jong, van der Heijde, McKenna & Whalley, 1997). This is a self-administered 30 item measure that is answered on a yes/no basis. 3. In addition two measures of physical function developed by Escalante, Hass, and Del Rincon (2004) will be used to provide reproducible, quantitative and objective information about the individual?s current level of functional strength and dexterity. One, Grip Strength measured with a device such as a hand-held dynamometer (digital versions available). In a sitting position, with the elbow held at 90 degrees and the forearm supported on a flat horizontal surface, the person is asked to squeeze the handle with as much strength as possible. Three repetitions for each hand will be obtained and the mean value for all repetitions for each hand will be recorded. The second measure of physical function is the Timed Button Test in which the participant is asked to wear a standard 8 button men's or women's extra large shirt and fasten the front buttons. Stop watch timing is activated from the moment the person takes the shirt and is stopped when all the buttons have been fastened. Measurements for all the secondary endpoints are to be obtained at baseline, midway through the 6 week clinical trial, at the end of the clinical trial and finally at | — |
Countries
Canada
Outcome results
None listed