Effects of Sand Treatment on Osteoarthritis

NCT ID: NCT03943303

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2021-08-23

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.

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

Keywords

monazitc sands; radiation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Natural gamma radiation from the monazite sands

Intervention Type: RADIATION

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.

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.

Group Type: PLACEBO_COMPARATOR

Normal sands exposure patients

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Other Intervention Names

Natural beach black sands; No-monazite sands

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Vila Velha

OTHER

Sponsor Role: lead

Responsible Party

Denise Coutinho Endringer

Director of Research and graduate program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DENISE C Endringer, Dr

Role: PRINCIPAL_INVESTIGATOR

UVila Velha

Locations

Denise Coutinho Endringer

Vila Velha, Espírito Santo, Brazil

Countries

Brazil

References

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.

Reference Type: RESULT

PMID: 4899510 (View on PubMed)

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

Reference Type: RESULT

PMID: 3068365 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and statistical analysis

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Document Type: Study Protocol and Informed Consent Form: Inform consent

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Document Type: Study Protocol: Pharmaceutical care

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Document Type: Study Protocol: Screening_log

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Document Type: Study Protocol: Enrolment _log

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Document Type: Study Protocol: Withdrawal_log

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Document Type: Study Protocol: Telephone_Contact_Log

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Document Type: Study Protocol: Meeting_minutes_template

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Related Links

http://www.theglobalhealthnetwork.org

The Global Health Network template.

Other Identifiers

TO#617/2018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

T015-M02-2019AF002

Identifier Type: -

Identifier Source: org_study_id