Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Thermotherapy Clinical Trial

Official title:

Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100541
• Other study ID #: CEPHCFMRPUSP-11099
• Status: Completed
• Phase: N/A
• First received: April 6, 2010
• Last updated: April 8, 2010
• Start date: February 2010
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In this study, the polymeric plate is prepared using the following procedure:

1. - the water is heated to the boiling temperature

2. - the heater is shut down

3. - the polymeric plate is immersed in water

4. - it rests in the water for 15 minutes

5. - 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Good communication and comprehension

• Skin integrity

Exclusion Criteria:

• Reduced skin sensitivity

• Disturbance in the central nervous system

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fever
• Polymers
• Therapeutic Hyperthermia
• Thermotherapy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Interunits postgraduate program in bioengineering	Sao Carlos	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of the polymeric plate	Acceptance of the polymeric plate by the volunteers.	2 weeks	No
Secondary	Polymeric plate comfort	Perception of the volunteers about the comfort of the polimeric plate.	2 weeks	No
Secondary	Polymeric plate temperature	Perception of the volunteers about the polymeric plate temperature.	2 weeks	No
Secondary	Polymeric plate time of heat retention	Perception of the volunteers about the polymeric plate time of heat retention.	2 weeks	No
Secondary	Sensation on the superficial touch of the polymeric plate	Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.	2 weeks	No
Secondary	Appearance of the polymeric plate	Perception of the volunteers about the appearence of the polymeric plate.	2 weeks	No
Secondary	Polymeric plate weight	Perception of the volunteers about the polymeric plate weight.	2 weeks	No
Secondary	Polymeric plate practicality	Perception of the volunteers about the polymeric plate practicality.	2 weeks	No
Secondary	General observations about the polymeric plate	General comments, suggestions and complaints of the volunteers about the polymeric plate.	2 weeks	No

External Links

•   Teaching hospital of the medical faculty of the University of Sao Paulo