Knee Joint Pain
Conditions
Brief summary
This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration.
Interventions
DRUGPlexoZome® Levagen® topical spray solution
PlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump
DRUGPlacebo topical spray solution
Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 20 years * Generally healthy * Able to provide informed consent * Undertaking regular exercise * Experiencing post exercise knee pain of at least 3 (on a 0-10 scale) at least 2 times in previous 4 weeks * Agree not to change current diet and/or exercise frequency or intensity
Exclusion criteria
* Serious illness( 1 ) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions * Unstable illness( 2 ) e.g., diabetes and thyroid gland dysfunction * Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy * Active smokers, nicotine use, alcohol( 3 ) or drug (prescription or illegal substances) abuse * Allergic to any of the ingredients in the active or placebo formula * Pregnant or lactating women * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion Footnotes ( 1 )A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. ( 2 )An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. ( 3 )Chronic past and/or current alcohol use (\>14 alcohol drinks/week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint pain | Up to 5 knee pain treatment events for up to 4 weeks | Joint pain via Visual Analogue Scale (VAS) Pain Scale which requires a pain rating from 1 to 10 with 1 indicating no pain and 10 indicating worse pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to pain relief | Up to 5 knee pain treatment events for up to 4 weeks | Time to pain relief via Visual Analogue Scale (VAS) Pain Scale which requires a pain rating from 1 to 10 with 1 indicating no pain and 10 indicating worse pain possible. |
| Number of Adverse Events | Enrolment period | Number of Adverse Events via AE monitoring |
| Severity of Adverse Events | Enrolment period | Severity of Adverse Events via AE monitoring |
| Rescue medication use | Up to 5 knee pain treatment events for up to 4 weeks | Rescue medication use via self-report |
Countries
Australia
Outcome results
None listed