Effect of an Intra-articular Treatment With a Combination of Hyaluronic Acid and Adelmidrol (Hyadrol®) on Pain, Joint Stiffness and Functional Limitation in Patients With Degenerative Joint Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change of degenerative joint disease symptoms in patients with coxarthrosis:
研究概览
简要总结
Osteoarthritis is a major cause of chronic musculoskeletal pain. Behind this disorder there is a process of chronic neuroinflammation due to the overactivation of mast cells at the tissue level. The mast cells present in the synovial membranes act as first sensors in pathological situations, degranulating in an uncontrolled manner.
Furthermore, in degenerative joint pathologies, there is a marked reduction in the viscoelastic capacity of the synovial fluid associated with a reduction in both the concentration and the average molecular weight of endogenous hyaluronic acid. The association of hyaluronic acid and Adelmidrol (Hyadrol®) could represent an effective treatment for controlling the neuroinflammation process that supports degenerative joint diseases.
The objective of the present clinical investigation is to evaluate its safety and efficacy in patients with arthritis of the hip (coxarthrosis) and trapezium-metacarpal joints (rhizoarthrosis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 40 years;
- •both genders;
- •diagnosis of stage II-III coxarthrosis or rhizoarthrosis according to radiological classification (Kellgren and Lawrence or modified Eaton-Littler criteria respectively)
- •pain intensity ≥ 5 on NRS;
- •wash-out for at least two weeks from anti-inflammatory drugs before enrollment;
- •compliant patients;
- •signed informed consent.
排除标准
- •age < 40 years;
- •presence of concomitant inflammatory systemic pathologies (e.g.: rheumatoid arthritis, etc.);
- •severe and progressive clinical conditions,
- •NSAIDs therapy in the 2 weeks prior to enrollment;
- •corticosteroid therapy in the 3 months prior to enrollment;
- •chondroprotectors intake in the 6 months prior to enrollment;
- •arthroscopic procedures or intra-articular visco-supplementation in the 6 months prior to enrollment;
- •presence of cognitive impairment;
- •ongoing rehabilitation and/or physiotherapy;
- •allergy or hypersensitivity to the study treatment;
- •pregnant and/or lactating female subjects;
- •not compliant patients;
- •denied informed consent.
结局指标
主要结局
Change of degenerative joint disease symptoms in patients with coxarthrosis:
时间窗: Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3
Evaluation of degenerative joint disease symptoms assessed by Western Ontario and McMaster Universities (WOMAC) scale for patients with coxarthrosis. WOMAC is a self-report questionnaire consisting of 24 questions divided into 3 groups: pain (5 items), joint stiffness (2 items) and functional limitations (17 items). Each question has 5 possible answers, evaluate in 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).
Change of degenerative joint disease symptoms in patients with rhizoarthrosis:
时间窗: Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3
Evaluation of degenerative joint disease symptoms assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaires for patients with rhizoarthrosis.The questionnaire is divided into 3 modules: symptom/disability module consisting of 30 questions investigating aspects of daily life; occupational module and sports/recreational activities module (optional) consisting of 8 questions in total. Optional items are used for workers and individuals whose occupation or sports or recreational activity requires a high level of physical performance. Each question has 5 possible answers, from 1 (no difficulty) to 5 (unable to perform a specific activity). The sum of the individual scores results in an overall score, which is converted into a scale from 0 to 100 (100 indicates severe disability).
次要结局
- Change of pain symptoms:(Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3)
- Change of patients quality of life:(Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3)
- Change of patients self-assessed health status:(Follow up (T3): one week after the last infiltration; Follow up (T4): four weeks after T3)
- Incidence of Adverse Events (Safety and Tolerability):(Baseline (T0): first intra-articular infiltration; Treatment (T1): second intra-articular infiltration; Treatment (T2): third intra-articular infiltration; Follow up (T3): 1 week after T2; Follow up (T4): 4 weeks after T3)
研究者
Maria Chiara Vulpiani
Associate Professor
University of Roma La Sapienza