Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.
25. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Enrico Polati
- Telefonnummer: +39 045 812 6076
- E-post: enrico.polati@aovr.veneto.it
Studiesteder
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Verona, Italia
- Azienda Ospedaliera Universitaria Integrata Verona
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Ta kontakt med:
- Enrico Polati
- E-post: enrico.polati@aovr.veneto.it
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Oral administration of m-/um-PEA, one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in joint symptoms and function
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in WOMAC score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Enrico Polati, Università di Verona, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno-Infantili
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
- 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
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
25. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
2. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Muskel- og skjelettsykdommer
- Sykdommer i nervesystemet
- Patologiske prosesser
- Leddgikt
- Leddsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Betennelse
- Artrose
- Patologiske tilstander, tegn og symptomer
- Hud- og bindevevssykdommer
- Nevroinflammatoriske sykdommer
- Artrose, kne
- Leddgikt, revmatoid
Andre studie-ID-numre
- KneeGrease
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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