Hyaluronic Acid in the Management of Articular Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pain change
研究概览
简要总结
This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2
详细描述
This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.
The first efficacy end-point will be:
the statistically significant difference (P<0.05) in VAS scale between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes between 18 and 65 years old, with a Body Mass Index < 29 kg/m
- •Patients with second- or third-degree of OA
- •Patients with VAS (Visual Analogue Scale) intensities higher than 5/10 who did not respond to systemic medication therapy.
- •Patients who can comprehend the study's objectives and (adhere to the orthopedist's instructions, return for follow-up, and complete the evaluation questionnaires).
- •Patients able to provide their written informed consent to participate to the study and to use their data anonymously for scientific purposes
排除标准
- •presence of active malignancy of any type or history of malignancy
- •Local or systemic infection.
- •Uncooperative patient or suffering from neurological disorders, therefore unable to follow the orthopedist's instructions or unable to provide informed consent for participation in the study or who have not provided written consent.
- •Any case not described in the inclusion criteria.
结局指标
主要结局
pain change
时间窗: 12 months
Numeric Pain Rating Scale: with a 0-10 points, where 0 is no pain and 10 is extreme pain
mood anxiety : zung scale
时间窗: 12 months
20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety
次要结局
- mood depression: zung scale(12 months)
研究者
Luca Gallelli
Clinical Professor
University of Catanzaro