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

Starting soon · Not applicable

Conditions studied: Degenerative Joint Disease of Knee, Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT07680101

Run by

Universita di Verona

People needed

80

Starts

2026-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Baseline WOMAC score ≥ 20
• Drug therapy stabilized for at least 3 months in the case of patients with rheumatoid arthritis
• Naïve to palmitoylethanolamide treatment
• Signed informed consent

You may not qualify if…

• 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
• Systemic treatment with chondroprotectors within 1 month prior to enrollment
• Systemic corticosteroid treatment within 1 month prior to enrollment
• Chronic Non-Steroidal Anti-Inflammatory Drugs (NSAID) therapy
• Pregnancy or breastfeeding
• Known hypersensitivity to study treatments

Where it is running

• Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.