Chronic Pain
Conditions
Brief summary
To perform a clinical proof-of-concept study on a novel topical formula for pain relief.
Detailed description
An open-label study where each participant will be involved in the study for 4 weeks. During the study participants will use the topical cream 1-2 times daily on the anatomical area(s) causing the most pain.
Interventions
Topical cream applied to painful joint or muscle
Sponsors
Study design
Intervention model description
An open-label study design where all study participants will receive the active test product and no placebo is used.
Eligibility
Inclusion criteria
* BMI between 18.5 and 34.9 kg/m2 (inclusive) * Chronic joint/muscle related pain for at least past 6 months * Experiencing chronic pain in at least one specific anatomical area for more than 6 months.
Exclusion criteria
* Cancer during past 12 months * Chemotherapy during past 12 months * Currently taking prescription pain medications * Getting regular joint injections (such as cortisone shots); * Immunization during last month * Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change * Regularly experiencing headaches, including migraines * Serious active illness within past 6 months * Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). * Skin allergies related to ingredients in test product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in degree of pain | 4 weeks | Pain questionnaire - yes/no, score 0-24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity level | 4 weeks | Activities of daily living questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wellness | 4 weeks | Wellness questionnaire - Score 0-10 \[0 being strongly disagree, 10 being strongly agree\] |
Countries
United States