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Knee injections with or without a PEA supplement for knee pain from joint wear

Compares knee injections of adelmidrol and hyaluronic acid, with or without PEA, in knee arthritis.

Plain-language title generated from the registry record
Registry title: Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.

Key facts

Where
Verona, ItalySee the site

Where in Italy

  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyNo longer taking part

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Trial details

Who runs it
Universita di Verona
Trial code
NCT07680101
Record updated
2 July 2026
Original description
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.Read full original descriptionShow less

Efficacy of Intra-articular Treatment With Adelmidrol 2% / Hyaluronic Acid 1%, With or Without m/umPEA, in Knee Pain Due to Joint Degeneration: a Bicentric, Prospective, Randomized Study.

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.

Inclusion: 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.

Exclusion: 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; Severe progressive systemic diseases; Known hypersensitivity to study treatments; Contraindications to intra-articular knee injections; Pregnancy or breastfeeding.

ClinicalTrials.gov NCT07680101