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

N/ANot Yet RecruitingNCT07680101

Universita di Verona80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Joint Disease of Knee Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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)

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)

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

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.

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

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).

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