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Effects of Sand Treatment on Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Natural gamma radiation from the monazite sands
Normal sands exposure patients
Sponsored by
University Vila Velha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteo Arthritis Knee focused on measuring monazitc sands, radiation

Eligibility Criteria

30 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Denise Coutinho Endringer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Natural gamma radiation from the monazite sands

Normal sands exposure patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Change the frequency of Self-medicatition to treat pain
Evaluation of the frequency of self-medication before and during the intervention

Full Information

First Posted
April 29, 2019
Last Updated
October 20, 2021
Sponsor
University Vila Velha
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1. Study Identification

Unique Protocol Identification Number
NCT03943303
Brief Title
Effects of Sand Treatment on Osteoarthritis
Official Title
Effect of Monazite Sands in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Because the Pandemia COVID-19 was not possible to bring the participants to the beach.
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Vila Velha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
monazitc sands, radiation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor is unaware of the treatment that the patients received.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural gamma radiation from the monazite sands
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal sands exposure patients
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Natural gamma radiation from the monazite sands
Other Intervention Name(s)
Natural beach black sands
Intervention Description
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
Intervention Name(s)
Normal sands exposure patients
Other Intervention Name(s)
No-monazite sands
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Visual analgesic scale (0-10)
Description
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.
Time Frame
1, 3, 6, 8 and 12 months
Secondary Outcome Measure Information:
Title
Change total score (0 - 96) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- (lower scores indicate lower levels of symptoms or physical disability)
Description
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.
Time Frame
1, 3, 6, 8 and 12 months
Title
Change the number of patient with higher concentration of Nonspecific inflammatory markers
Description
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
Time Frame
1, 3, 6, 8 and 12 months
Title
Change the frequency of Self-medicatition to treat pain
Description
Evaluation of the frequency of self-medication before and during the intervention
Time Frame
1, 3, 6, 8 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DENISE C Endringer, Dr
Organizational Affiliation
UVila Velha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denise Coutinho Endringer
City
Vila Velha
State/Province
ES
ZIP/Postal Code
29103790
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
4899510
Citation
Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. No abstract available.
Results Reference
result
PubMed Identifier
3068365
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.
Results Reference
result
Links:
URL
http://www.theglobalhealthnetwork.org
Description
The Global Health Network template.

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Effects of Sand Treatment on Osteoarthritis

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