Efficacy and Safety of Non-animal Chondroitin Sulphate Supplementation in the Treatment of Moderate Knee Osteoarthritis in a Group of Overweight Subjects: a Randomized, Double Blind, Placebo-controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Generic Pain (VAS)
研究概览
简要总结
Knee osteoarthritis (OA) is predicted to become the fourth leading cause of disability worldwide by 2020. and is estimated to affect more than 40 million people in Europe and 4 million people in Italy. OA has multifactorial etiology and obesity is one of the most important risk factor for knee Regarding therapy of OA in 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee OA. In Step 1 of the treatment, it is recommended to initiate therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Among SYSADOAs, the evidence is greatest for the effect of chondroitin sulfate (CS).
Sixty overweight subjects with knee osteoarthritis (OA) were recruited and randomly allocated to a group of treatment with 600 mg/d of non-animal Chondroitin sulphate (CS) or to a placebo group.
These measurements were considered:
Tegner Lysholm Knee Scoring (TLKS), Western Ontario and McMaster Universities Arthritis (WOMAC) index and Visual Analogue Scale (VAS) for pain were analyzed at time 0 and at 4 and 12 weeks. Health-related quality of life by ShortForm36, inflammation by C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were also evaluated, together with a body composition assessment performed by DXA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Full randomization and full blind study. Intervention was named by "integratore A" and "integratore B"
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian subjects, males and females, with the following characteristics were included in the trial and randomly assigned to the experimental group (N=30) or a control group (N=30): Individuals overweight (BMI > 25 kg/m2), aged 40-74.; Mobility impairment, joint discomfort or established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA).
排除标准
- •Anyone with evidence of heart disease, kidney or liver disease, or any other disease that might influence the results of the study was excluded.
结局指标
主要结局
Change in Generic Pain (VAS)
时间窗: 0, 30, 90 days
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain. A VAS reduction is expected only in treatment group.
Change in Knee Pain (WOMAC)
时间窗: 0, 30, 90 days
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations. A significant decrease in expected in treatment group.
Change in Knee Functionality (TLKS)
时间窗: 0, 30, 90 days
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability. An increase in expected in treatment group.
次要结局
- Change in Quality of Life (SF-36)(0, 30, 90 days)
- Change in total Fat Mass, Total Free Fat Mass and Visceral adipose tissue (DXA)(0, 30, 90 days)
- Change in Inflammatory Markers circulating levels (CRP, ESR)(0, 30, 90 days)
研究者
Mariangela Rondanelli
MD, Associate Professor
University of Pavia