Effect of Monazite Sands in Patients With Osteoarthritis of the Knee
Phase: NA
Conditions: Osteo Arthritis Knee
Sponsor: University Vila Velha

 
 
 
 
Document date: May 2nd , 2019
Official Title: 
Effect of Monazite Sands in Patients with Osteoarthritis 
of the Knee 
Ethical committee Protocol No: 3.160.891  
 
Inform consent 

INFORM CONSENT TERM (TCLE) 
 
Effect of monazite sands in patients with osteoarthritis of the knee 
Responsible for research: Prof. Dr Denise Coutinho Endringer and Dr. Marcio 
Fronza 
 
 
This document you are reading is called the Free and Informed Consent Term 
(TCLE). It contains explanations about the study you are being asked to attend. Before 
deciding whether to participate (of your own free will) you should read and 
understand all the content. In the end, if you decide to participate, you will be asked 
to sign it and you will receive a copy of it. Before signing, ask questions about 
anything you did not understand well. The study team will respond to your questions 
at any time (before, during and after the study). Your participation is voluntary, which 
means that you can withdraw at any time, withdrawing your consent, without any loss 
or penalty, by contacting one of the responsible researchers. 
 
This research seeks to prove the beneficial effects of radiation emitted by the monazite 
sands in patients with osteoarthritis of the knee in order to prove and divulge to the 
scientific community the real benefits of this radiation in patients with this disease. If 
you decide to accept the invitation, you will be subjected to the following procedures: 
Your affected knee (s) will be fully submerged in the sand of the beach 2 (two) times 
per week for 30 (thirty) minutes each session in the same place, and period of the day 
for a period of 12 (twelve) months. You will be evaluated clinically and submitted to 
questionnaires and blood collection in 7 moments (at the beginning of the research, 
after 1, 2, 3, 6, 9 and 12 months.) You can be chosen to participate in the control group 
(Itapoã beach sand ) or the group tested (sands of Areia Preta beach). 
 
The risks involved with their participation are: accidents during the bus trip (transit), 
problems in embarkation and / or disembarkation of buses, excessive heat that can 
occur on beaches, puncture accidents, phlebitis, skin infections and accidents with 
biological material during the blood collection, which will be minimized through the 
following measures: monitoring of employees and collaborating researchers during 
shipment, transfer, landing and during exposure to the sands, guarantee of biosafety 

standards during collection of biological material and use only properly inspected by 
the regulatory agencies. If this procedure can generate some kind of embarrassment 
you do not have to do it. 
 
You will have the following benefits when participating in the research: improvement 
of pain, stiffness and ability to perform your daily activities related to knee 
osteoarthritis. Their participation may help in further knowledge about the real benefit 
of monazite sands in patients with osteoarthritis of the knee. 
 
All information obtained will be confidential. The material with your information 
(recordings, interviews, among others) will be kept in a safe place under the 
responsibility of Prof. Dr. Marcio Fronza and Prof. Dr. Denise Coutinho Endringer 
with the guarantee of confidentiality and confidentiality that will be destroyed after 
the research. Dissemination of the results will be done in a way that does not identify 
the volunteers. The results of this work may be presented in meetings or scientific 
journals, however, it will only show the results obtained as a whole, without revealing 
its name, institution to which it belongs or any information related to its privacy. 
 
As provided by the Brazilian research standards with the participation of human 
beings you will not receive any type of financial compensation for your participation 
in this study. If you have any expense that is due to your participation in the survey, 
you will be reimbursed if you request it. At any time, if you experience any damage 
from this research, you will be entitled to compensation. 
 
You will be left with a route to this Term and any questions you may have regarding 
this research, you may ask directly to Prof. Dr. Marcio Fronza or Prof. Dr. Denise 
Coutinho Endringer, Rua José Dantas de Melo, nº 21, Boa Vista, Vila Velha-ES, CEP: 
29.102-770, Tel .: (27) 3421-2087. 
 
Doubts about the research involving ethical principles may be questioned to the UVV 
Research Ethics Committee located in the Rectory building in the basement: at Rua 
José Dantas de Melo, nº 21, Boa Vista, Vila Velha-ES, CEP: 29.102-770, Tel .: (27) 
3421-2063, E-mail: 

cep@uvv.br. Opening hours: Monday to Friday from 07h to 12h and from 13h to 17h 
and Friday from 07h to 12h and from 13h to 16h. Secretary: Sirlene Gomes Neves. 
Complaints and / or dissatisfactions related to the patient's participation in the research 
may be communicated in writing to the CEP / UVV Secretariat, provided that the 
claimants identify themselves, and their name will be kept anonymous. 
 
 
 
Consent 
 
 
Signature of the Principal Investigator: _____________________Date____________ 
Signature of the Patient: ________________________________Date____________