Effects of Sand Treatment on Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Effect of Monazite Sands in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03943303
• Other study ID #: T015-M02-2019AF002
• Secondary ID: TO#617/2018
• Status: Terminated
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: August 23, 2021

Study information

• Verified date: October 2021
• Source: University Vila Velha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: August 23, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Denise Coutinho Endringer	Vila Velha	ES

Sponsors (1)

Lead Sponsor	Collaborator
University Vila Velha

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change the number of patient with higher concentration of Nonspecific inflammatory markers	Quantification of nonspecific inflammatory markers (HSV and CRP) and specific (IL-1ß, IL-6, IL-8, IL-17, TNF-a and TGF-ß) per patient	1, 3, 6, 8 and 12 months
Secondary	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

External Links

•   The Global Health Network template.