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Effects of Sand Treatment on Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943303
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Denise Coutinho Endringer, University Vila Velha

Brief 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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Radiation: Natural gamma radiation from the monazite sands Radiation: Normal sands exposure patients Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be carried out on the beaches of Areia Preta de Guarapari (source of monazitic sands) and on the beach of Itapoã in Vila Velha (sand without radiation). Selected patients will have their knees fully covered with beach sand, properly analyzed for radioactivity and temperature, for 30 minutes on 2 mornings a week for a period of 1 (one) year.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor is unaware of the treatment that the patients received.
Primary Purpose: Health Services Research
Official Title: Effect of Monazite Sands in Patients With Osteoarthritis of the Knee
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : December 23, 2019
Estimated Study Completion Date : August 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Natural beach black sands

Placebo Comparator: 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.
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.
Other Name: No-monazite sands




Primary Outcome Measures :
  1. Change in the Visual analgesic scale (0-10) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability) [ Time Frame: 1, 3, 6, 8 and 12 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire comprises three subscale. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.

  2. Change the number of patient with higher concentration of Nonspecific inflammatory markers [ Time Frame: 1, 3, 6, 8 and 12 months ]
    Quantification of nonspecific inflammatory markers (HSV and CRP) and specific (IL-1β, IL-6, IL-8, IL-17, TNF-α and TGF-β) per patient

  3. Change the frequency of Self-medicatition to treat pain [ Time Frame: 1, 3, 6, 8 and 12 months ]
    Evaluation of the frequency of self-medication before and during the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Joint pain related to daily activities;
  • No morning joint stiffness greater than 30 minutes;
  • Age between 30 and 95 years.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943303


Contacts
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Contact: DENISE C ENDRINGER, Dr +552732412146 denise.endringer@uvv.br
Contact: Marcio Fronza, Dr +552732412187 marcio.fronza@uvv.br

Locations
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Brazil
Denise Coutinho Endringer Recruiting
Vila Velha, ES, Brazil, 29103790
Contact: DENISE C ENDRINGER, Dr    +552734212146    denise.endringer@uvv.br   
Contact: Marcio Fronza    +552732412187    marcio.fronza@uvv.br   
Sponsors and Collaborators
University Vila Velha
Investigators
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Principal Investigator: DENISE C Endringer, Dr UVila Velha
  Study Documents (Full-Text)

Documents provided by Denise Coutinho Endringer, University Vila Velha:
Study Protocol: Screening_log  [PDF] May 3, 2019
Study Protocol: Enrolment _log  [PDF] May 2, 2019
Study Protocol: Withdrawal_log  [PDF] May 3, 2019

Additional Information:
Publications of Results:
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Responsible Party: Denise Coutinho Endringer, Director of Research and graduate program, University Vila Velha
ClinicalTrials.gov Identifier: NCT03943303    
Other Study ID Numbers: T015-M02-2019AF002
TO#617/2018 ( Other Grant/Funding Number: FUNCITEC/MCI )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denise Coutinho Endringer, University Vila Velha:
monazitc sands
radiation
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases