About this trial
Degenerative knee joint diseases are characterized by chronic pain, inflammation, and functional impairment. In these conditions, mast cell density in the synovial membrane is increased, resulting in an excessive release of biological mediators involved in key mechanisms of neuroinflammation and in hyaluronic acid depolymerisation. Adelmidrol acts as a preventive antioxidant due to its radical scavenging activity, thus protecting hyaluronic acid from oxidative degradation and reducing mast cell degranulation. Furthermore, a reduction in endogenous Palmitoylethanolamide (PEA) levels also contributes to joint neuroinflammation and disease progression; therefore, its exogenous supplementation may represent a valuable supportive strategy.
The objective of this clinical investigation is to compare the efficacy of intra-articular adelmidrol/hyaluronic acid treatment alone versus the same intra-articular treatment combined with oral micronized /ultramicronized PEA in patients with knee joint degeneration due to osteoarthritis or rheumatoid arthritis.
Eligibility criteria
Qualifiers
Age ≥ 40 years
Male or female
Diagnosis of unilateral or bilateral knee joint degeneration due to osteoarthritis or rheumatoid arthritis, Kellgren-Lawrence grade II-III
Duration of knee pain ≥ 6 months
Disqualifiers
Severe progressive systemic diseases
Contraindications to intra-articular knee injections
Intra-articular knee injections within 3 months prior to enrollment
Knee surgery within 6 months prior to enrollment
Trial design
Treatments tested in this trial
- Adelmidrol 2% / Hyaluronic Acid 1%
- micronized Palmitoylethanolamide (mPEA) 300mg + ultramicronized Palmitoylethanolamide (umPEA) 600mg
Treatment groups
Locations
1Sponsors and collaborators
Universita di Verona
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator