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| Name | Class |
|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Hyadrol®) | Active Comparator | Participants receive intra-articular injections of adelmidrol 2% / hyaluronic acid 1% (Hyadrol®) administered once weekly for three consecutive weeks. |
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| Group B (Hyadrol® + m-/um-PEA) | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adelmidrol 2% / Hyaluronic Acid 1% | Device | Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in joint symptoms and function | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC score | 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). | Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Polati | Contact | +39 045 812 6076 | enrico.polati@aovr.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Enrico Polati | Università di Verona, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno-Infantili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36291664 | Background | Guida F, Rocco M, Luongo L, Persiani P, Vulpiani MC, Nusca SM, Maione S, Coluzzi F. Targeting Neuroinflammation in Osteoarthritis with Intra-Articular Adelmidrol. Biomolecules. 2022 Oct 11;12(10):1453. doi: 10.3390/biom12101453. |
| Label | URL |
|---|---|
| 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 | View source |
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| micronized Palmitoylethanolamide (mPEA) 300mg + ultramicronized Palmitoylethanolamide (umPEA) 600mg | Dietary Supplement | Oral administration of m-/um-PEA, one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks. |
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| Change in pain intensity | 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. | Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5) |
| Change in patients' quality of life | 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. | Baseline (T0), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5) |
| Incidence of Treatment-Related Adverse Events (Safety and Tolerability) | Treatment safety is assessed by monitoring the incidence and severity of adverse events immediately after injections and throughout the study. | From first treatment administration up to 6 months after treatment |
| Change in analgesic consumption | 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. | Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5) |
| Change of patients' self-assessed health status | 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). | 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5) |
| 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. | View source |
| 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 | View source |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001172 | Arthritis, Rheumatoid |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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