Effect of Monazite Sands in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in the Visual analgesic scale (0-10)
研究概览
简要总结
2528/5000 Historically the city of Guarapari / ES is known as the city health by the popular therapeutic effect of its sands in diverse diseases. The articular diseases are among the list of the aggravations that popularly the monazitic sands exert some therapeutic effect, emphasizing. Rheumatic diseases include osteoarthritis of the knee. It is a disease with a high prevalence and in recent years have presented an increase in the incidence supposedly caused by the aging population and due to the epidemic of obesity. Osteoarthrosis is proven to be a disease that leads to the incapacity and restriction of the individual's ability to come and go with high monetary costs for the patient and the government. In view of these facts presented, the objective is to investigate the therapeutic potential of monazite sands in elderly patients submitted to serial, controlled and standardized exposure, compared to patients exposed to beach sand without radiation.
详细描述
A sample of 150 patients with primary knee osteoarthrosis will be selected for the study, divided into two random groups that will be exposed to sand (one monazite sand group and another beach sand group without radiation) for 12 months. The groups will be evaluated at time 0 (at the patient's arrival in the group) and at 1, 2, 3, 6, 9 and 12 months of exposure following the literature criteria for evaluation of knee osteoarthrosis (Visual Analogue Scale (EVA) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) and non-specific and specific biomarkers (C-reactive protein, erythrocyte sedimentation rate, IL-1β, IL-6, IL-8, TGF-β, and TNF-α). In addition, the groups will undergo an initial interview and monitoring of the pharmacological therapies used prior to the study and during the months of follow-up using the Dáder methodology of pharmaceutical care adapted to the study. As a result, the scientific evidence of the efficacy of monazitic sands in knee osteoarthrosis is expected not only by clinical criteria but also by laboratory evidence on the markers of the inflammatory and degenerative process that allow us to document the real value of the monazitic sands for health of the population, to establish a great line of research for the state of Espírito Santo and to value the State of Espírito Santo and the municipality of Guarapari as potential itineraries for SPA tourism (aiming to improve health).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is unaware of the treatment that the patients received.
入排标准
- 年龄范围
- 30 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joint pain related to daily activities;
- •No morning joint stiffness greater than 30 minutes;
- •Age between 30 and 95 years.
排除标准
- •History of previous knee surgery.
- •History of fracture in the knee region.
- •History of any secondary OA associated with any cystic arthropathy.
- •Any treatment for the knee with methotrexate.
- •History of hemorrhagic disorders.
- •History of any infiltration of the knee during the previous 6 months (eg corticosteroids and hyaluronic acid).
- •Morbid obesity.
- •History of severe psychiatric disorders.
- •History of skin cancer.
研究组 & 干预措施
Natural gamma radiation from the monazite sands
Patients selected for the study will have their knee (s) affected by osteoarthrose fully submerged in the monazite beach sand 2 (two) times per week for 30 (thirty) minutes each session at the same location and at the same time of day. The natural gamma radiation doses of the monazite sands will be monitored, the radiation measurements gamma will be associated with the atmospheric and climatic measurements of each group. It is understood here as atmospheric measurements, level of solar radiation, spectrum of sunlight at the time of exposure, humidity, wind speed, ultraviolet radiation level, amount of ions present in the air and measurements of the magnetic field in the place.
干预措施: Natural gamma radiation from the monazite sands (Radiation)
Normal sands exposure patients
Patients selected for the study will have their knee (s) affected by osteoarthrose fully submerged in the no-monazite beach sand 2 (two) times per week for 30 (thirty) minutes each session at the same location and at the same time of day. To ensure the absence of radiation, mesuaraments of possible radiation will be monitored.
干预措施: Normal sands exposure patients (Radiation)
结局指标
主要结局
Change in the Visual analgesic scale (0-10)
时间窗: 1, 3, 6, 8 and 12 months
Change pain perception through the visual analgesic scale of the volunteers. It consists of a graduated scale of 0 to 10 with regular intervals where zero means absence of pain and 10 is the maximum pain already experienced by the patient.
次要结局
- Change the frequency of Self-medicatition to treat pain(1, 3, 6, 8 and 12 months)
- Change the number of patient with higher concentration of Nonspecific inflammatory markers(1, 3, 6, 8 and 12 months)
- Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability)(1, 3, 6, 8 and 12 months)
研究者
Denise Coutinho Endringer
Director of Research and graduate program
University Vila Velha