Clinical trial NCT03943303: Effects of Sand Treatment on Osteoarthritis
Official title: Effect of Monazite Sands in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: monazitc sands
radiation
Lead sponsor: University Vila Velha
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Change in the Visual analgesic scale (0-10)
timeFrame: 1, 3, 6, 8 and 12 months
Secondary outcomes:
measure: Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability)
timeFrame: 1, 3, 6, 8 and 12 months
measure: Change the number of patient with higher concentration of Nonspecific inflammatory markers
timeFrame: 1, 3, 6, 8 and 12 months
measure: Change the frequency of Self-medicatition to treat pain
timeFrame: 1, 3, 6, 8 and 12 months
Other outcomes:
Locations:
city: Vila Velha
country: Brazil
facility: Denise Coutinho Endringer
state: ES
Study officials:
affiliation: UVila Velha
name: DENISE C Endringer, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. J Rheumatol. 1988 Dec;15(12):1833-40.