The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation

Inclusion criteria

• Signed written informed consent before inclusion in the investigation.
• Any gender, any ethnic origin, 19-69 years old inclusive.
• Body Mass Index 18.5-40 kg/m2 inclusive.
• Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation.
• Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity > 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid.
• Availability of a radiography of the selected knee not older than 6 months.
• Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit

Exclusion criteria

• Clinically significant abnormal physical findings which could interfere with the objectives of the investigation
• History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation.
• Significant history of diseases that may interfere with the aim of the clinical investigation.
• History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee.
• Presence of flares, inflammation, effusion and swelling at the selected knee.
• Any skin injury, wound, irritation, rash, bump, sore and/or discoloration at the application area.
• Surgery at the selected knee in the 12 months preceding the clinical investigation.
• Any medication that could interfere with the investigation procedures or investigation outcome.
• Use of other hot or cold therapies for the selected knee.
• Positive pregnancy test at screening; pregnant or breastfeeding women
• History of (within the past 12 months) or current drugs or alcohol abuse
• Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.