Effects of Sand Treatment on Osteoarthritis

NCT03943303 | Terminated

• 2 other identifiers: T015-M02-2019AF002TO#617/2018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

monazitc sands; radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability)

  1, 3, 6, 8 and 12 months

• Change the number of patient with higher concentration of Nonspecific inflammatory markers

  1, 3, 6, 8 and 12 months

• Change the frequency of Self-medicatition to treat pain

  1, 3, 6, 8 and 12 months

Study Arms (2)

Natural gamma radiation from the monazite sands

EXPERIMENTAL

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

Normal sands exposure patients

PLACEBO COMPARATOR

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

Interventions

Natural gamma radiation from the monazite sands 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.

Also known as: Natural beach black sands

Natural gamma radiation from the monazite sands

Normal sands exposure patients 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.

Also known as: No-monazite sands

Normal sands exposure patients

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Vila Velha: lead

Study Sites (1)

Denise Coutinho Endringer

Vila Velha, Espírito Santo, 29103790, Brazil

Location

Related Publications (2)

• 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.

  PMID: 4899510 RESULT

• 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.

  PMID: 3068365 RESULT

Related Links

• The Global Health Network template.

Study Officials

• DENISE C Endringer, Dr

  UVila Velha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is unaware of the treatment that the patients received.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and graduate program

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 9, 2019
• Study Start: July 28, 2021
• Primary Completion: July 28, 2021
• Study Completion: August 23, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)