Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversita di Verona

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universita di Verona

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator