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

ConditionsDegenerative Joint Disease of KneeRheumatoid Arthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversita di Verona

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adelmidrol 2% / Hyaluronic Acid 1%

    Device

    Ultrasound-guided intra-articular knee injection, 2 mL per injection, administered once weekly for three weeks.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group A (Hyadrol®)Active comparator 1 intervention
Group B: Group B (Hyadrol® + m-/um-PEA)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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): * 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).

Time frame
Baseline (T0) and 1 month after treatment (T3)

Secondary outcomes

1

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).

Time frame
Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5)
2

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.

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)
3

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.

Time frame
Baseline (T0), 1 month after treatment (T3), 3 months after treatment (T4) and 6 months after treatment (T5)
4

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.

Time frame
From first treatment administration up to 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universita di Verona

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator

Source ClinicalTrials.gov

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