Adelmidrol 2% / Hyaluronic Acid 1%: Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks.
micronized Palmitoylethanolamide (mPEA) 300mg + ultramicronized Palmitoylethanolamide (umPEA) 600mg: Oral administration of m-/um-PEA, one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks.
Study summary
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
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Change in joint symptoms and function — Baseline (T0) and 1 month after treatment (T3) Evaluation of degenerative joint disease symptoms and function assessed by Western Ontario and McMaster Universities (WOMAC) scale, a self-report questionnaire consisting of 24 questions divided in pain (5 items), joint stiffness (2 items) and functional limitations (17 items). Each question has 5 possible answers, evaluated on a Likert scale, from 0 (none) to 4 (extreme):
* pain: score from 0 to 20;
* joint stiffness: score from 0 to 8;
* functional limitations: score from 0 to 68.
The sum of the individual scores results in an overall score from 0 to 96 (96 indicates severe disability).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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