Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
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|ClinicalTrials.gov Identifier: NCT01100541|
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : April 9, 2010
The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.
The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.
|Condition or disease||Intervention/treatment||Phase|
|Therapeutic Hyperthermia Thermotherapy Polymers||Device: Polymeric plate||Not Applicable|
In this study, the polymeric plate is prepared using the following procedure:
- - the water is heated to the boiling temperature
- - the heater is shut down
- - the polymeric plate is immersed in water
- - it rests in the water for 15 minutes
- - it is inserted in a wrap
In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.
After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.
Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: Polymeric plate characteristics
Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics.
Device: Polymeric plate
Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.
- Acceptance of the polymeric plate [ Time Frame: 2 weeks ]Acceptance of the polymeric plate by the volunteers.
- Polymeric plate comfort [ Time Frame: 2 weeks ]Perception of the volunteers about the comfort of the polimeric plate.
- Polymeric plate temperature [ Time Frame: 2 weeks ]Perception of the volunteers about the polymeric plate temperature.
- Polymeric plate time of heat retention [ Time Frame: 2 weeks ]Perception of the volunteers about the polymeric plate time of heat retention.
- Sensation on the superficial touch of the polymeric plate [ Time Frame: 2 weeks ]Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.
- Appearance of the polymeric plate [ Time Frame: 2 weeks ]Perception of the volunteers about the appearence of the polymeric plate.
- Polymeric plate weight [ Time Frame: 2 weeks ]Perception of the volunteers about the polymeric plate weight.
- Polymeric plate practicality [ Time Frame: 2 weeks ]Perception of the volunteers about the polymeric plate practicality.
- General observations about the polymeric plate [ Time Frame: 2 weeks ]General comments, suggestions and complaints of the volunteers about the polymeric plate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100541
|Interunits postgraduate program in bioengineering|
|Sao Carlos, SP, Brazil, 13566-590|
|Principal Investigator:||Fabiula BM dos Santos, Physio||University of Sao Paulo|
|Study Director:||Valéria MC Elui, PhD||University of Sao Paulo|