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Not yet recruiting NCT07680101

Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.

No phase Interventional Degenerative Joint Disease of Knee Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adelmidrol 2% / Hyaluronic Acid 1%, micronized Palmitoylethanolamide (mPEA) 300mg + ultramicronized Palmitoylethanolamide (umPEA) 600mg.
Who it may be relevant to
Registry conditions: Degenerative Joint Disease of Knee, Rheumatoid Arthritis. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Device Adelmidrol 2% / Hyaluronic Acid 1%
    Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks.
  • Dietary supplement 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.

Primary outcome measures

  • Change in joint symptoms and function [Time frame: Baseline (T0) and 1 month after treatment (T3)]
Secondary outcome measures (6)
  • Change in WOMAC score [Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5)]
  • Change in pain intensity [Time frame: 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 [Time frame: 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) [Time frame: From first treatment administration up to 6 months after treatment]
  • Change in analgesic consumption [Time frame: 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 [Time frame: 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Azienda Ospedaliera Universitaria Integrata Verona — Verona

Publications

  • 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. PMID 36291664

Identifiers

NCT: NCT07680101 · KneeGrease

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗