Knee Joint Pain Clinical Trial
Official title:
Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
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.
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | May 1, 2025 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | RDC Clinical Pty Ltd | Brisbane | Queensland |
| Lead Sponsor | Collaborator |
|---|---|
| RDC Clinical Pty Ltd |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Joint pain | 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. | Up to 5 knee pain treatment events for up to 4 weeks | |
| Secondary | Time to pain relief | 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. | Up to 5 knee pain treatment events for up to 4 weeks | |
| Secondary | Number of Adverse Events | Number of Adverse Events via AE monitoring | Enrolment period | |
| Secondary | Severity of Adverse Events | Severity of Adverse Events via AE monitoring | Enrolment period | |
| Secondary | Rescue medication use | Rescue medication use via self-report | Up to 5 knee pain treatment events for up to 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02056470 -
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
|
N/A |