Effects of Sand Treatment on Osteoarthritis

Effect of Monazite Sands in Patients With Osteoarthritis of the Knee

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.

Study Overview

• Status: Terminated
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Radiation: Natural gamma radiation from the monazite sands; Radiation: Normal sands exposure patients

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).

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • ES
    • Vila Velha, ES, Brazil, 29103790
      • Denise Coutinho Endringer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: No-monazite sands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Visual analgesic scale (0-10)	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.	1, 3, 6, 8 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability)	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.	1, 3, 6, 8 and 12 months
Change the number of patient with higher concentration of Nonspecific inflammatory markers	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	1, 3, 6, 8 and 12 months
Change the frequency of Self-medicatition to treat pain	Evaluation of the frequency of self-medication before and during the intervention	1, 3, 6, 8 and 12 months

Collaborators and Investigators

• Sponsor: University Vila Velha
• Investigators: Principal Investigator: DENISE C Endringer, Dr, UVila Velha

Publications and helpful links

General Publications

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

Helpful Links

• The Global Health Network template.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2021
• Primary Completion (ACTUAL): July 28, 2021
• Study Completion (ACTUAL): August 23, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: radiation; monazitc sands
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: T015-M02-2019AF002; TO#617/2018 (OTHER_GRANT: FUNCITEC/MCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No