Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.
25 juni 2026 uppdaterad av: Universita di Verona
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Enrico Polati
- Telefonnummer: +39 045 812 6076
- E-post: enrico.polati@aovr.veneto.it
Studieorter
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Verona, Italien
- Azienda Ospedaliera Universitaria Integrata Verona
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Kontakt:
- Enrico Polati
- E-post: enrico.polati@aovr.veneto.it
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Group A (Hyadrol®)
Participants receive intra-articular injections of adelmidrol 2% / hyaluronic acid 1% (Hyadrol®) administered once weekly for three consecutive weeks.
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Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks.
Andra namn:
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Experimentell: Group B (Hyadrol® + m-/um-PEA)
Participants receive intra-articular injections of adelmidrol 2% / hyaluronic acid 1% (Hyadrol®) administered once weekly for three consecutive weeks, combined with oral micronized/ultramicronized palmitoylethanolamide (m-/um-PEA) (Normast® MPS), one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks.
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Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks.
Andra namn:
Oral administration of m-/um-PEA, one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in joint symptoms and function
Tidsram: Baseline (T0) and 1 month after treatment (T3)
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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):
The sum of the individual scores results in an overall score from 0 to 96 (96 indicates severe disability). |
Baseline (T0) and 1 month after treatment (T3)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in WOMAC score
Tidsram: Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5)
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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).
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Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5)
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Change in pain intensity
Tidsram: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Evaluation of pain intensity assessed by the Visual Analogue Scale (VAS) scored from 0 mm to 100 mm, where 0 indicates 'no pain' and 100 corresponds to 'the worst pain ever possible'.
The higher the score, the more severe the pain.
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Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Change in patients' quality of life
Tidsram: Baseline (T0), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Quality of Life evaluated by the 12-Item Short Form Health Survey (SF-12).
The SF-12 is a self-reported health questionnaire.
The score produces two summary measures: a mental (MCS-12) and a physical component score (PCS-12).
The PCS-12 score is derived from the subdimensions of general health, physical functioning, role physical, and bodily pain, while the MCS-12 score is derived from the subdimensions of social functioning, role emotional, mental health, and energy.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
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Baseline (T0), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Tidsram: From first treatment administration up to 6 months after treatment
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Treatment safety is assessed by monitoring the incidence and severity of adverse events immediately after injections and throughout the study.
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From first treatment administration up to 6 months after treatment
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Change in analgesic consumption
Tidsram: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Analgesic consumption is evaluated by the Cumulative Analgesic Consumption Score (CACS), an index that quantifies the overall use of analgesic medications, taking into account the type, dosage, and frequency of the different analgesics administered.
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Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Change of patients' self-assessed health status
Tidsram: 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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The patient's global health status is evaluated through the Likert Patient Global Impression of Change (PGIC) scored in 7 points (from 1, very much improved to 7, very much worse).
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1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Enrico Polati, Università di Verona, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno-Infantili
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
- Vulpiani MC, Vetrano M, Trischitta D, et al. Risultati a lungo termine del trattamento della gonartrosi mediante infiltrazioni intra-articolari di Hyadrol®. Giornale Italiano di Ortopedia e Traumatologia 2022;48:100-106
- Vulpiani MC et al., Hyaluronic acid alone versus hyaluronic acid associated with adelmidrol for Intra-articular treatment of knee osteoarthritis: A long-term follow -up. Int J Physiother Res 2023;11(1):4453-4460.
- Cavallaro C et al., Adelmidrol Protects Hyaluronic Acid against Oxidative Degradation and Improves the Outcome in Patients with Adhesive Capsulitis of the Shoulder Managed by Physical Therapy. J Orthop Res Ther2024
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
25 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Muskuloskeletala sjukdomar
- Sjukdomar i nervsystemet
- Patologiska processer
- Artrit
- Ledsjukdomar
- Reumatiska sjukdomar
- Bindvävssjukdomar
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Inflammation
- Artros
- Patologiska tillstånd, tecken och symtom
- Hud- och bindvävssjukdomar
- Neuroinflammatoriska sjukdomar
- Artros, knä
- Artrit, reumatoid
Andra studie-ID-nummer
- KneeGrease
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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