Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.
2026年6月25日 更新者：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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Enrico Polati
- 电话号码：+39 045 812 6076
- 邮箱：enrico.polati@aovr.veneto.it
学习地点
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Verona、意大利
- Azienda Ospedaliera Universitaria Integrata Verona
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接触：
- Enrico Polati
- 邮箱：enrico.polati@aovr.veneto.it
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
其他名称：
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实验性的：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.
其他名称：
Oral administration of m-/um-PEA, one sachet twice daily for 6 weeks, followed by 1 sachet daily for 8 weeks.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in joint symptoms and function
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in WOMAC score
大体时间：Baseline (T0), 1 week (T1), 2 weeks (T2), 3 months after treatment (T4) and 6 months after treatment (T5)
|
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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Change in pain intensity
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Enrico Polati、Università di Verona, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno-Infantili
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
- 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
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年6月25日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年7月2日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.