NCT03943303

Effects of Sand Treatment on Osteoarthritis

Effect of Monazite Sands in Patients With Osteoarthritis of the Knee

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Vila Velha · Academic / Other
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
RADIATION	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.
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.

Timeline

• Start date: 2021-07-28
• Primary completion: 2021-07-28
• Completion: 2021-08-23
• First posted: 2019-05-09
• Last updated: 2021-10-28

Locations

1 site across 1 country: Brazil