Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

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.

Study Overview

• Status: Completed
• Conditions: Thermotherapy; Therapeutic Hyperthermia; Polymers
• Intervention / Treatment: Device: Polymeric plate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Carlos, SP, Brazil, 13566-590
      • Interunits postgraduate program in bioengineering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good communication and comprehension
• Skin integrity

Exclusion Criteria:

• Reduced skin sensitivity
• Disturbance in the central nervous system

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: PPDOM; PPDCO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of the polymeric plate	Acceptance of the polymeric plate by the volunteers.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polymeric plate comfort	Perception of the volunteers about the comfort of the polimeric plate.	2 weeks
Polymeric plate temperature	Perception of the volunteers about the polymeric plate temperature.	2 weeks
Polymeric plate time of heat retention	Perception of the volunteers about the polymeric plate time of heat retention.	2 weeks
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
Appearance of the polymeric plate	Perception of the volunteers about the appearence of the polymeric plate.	2 weeks
Polymeric plate weight	Perception of the volunteers about the polymeric plate weight.	2 weeks
Polymeric plate practicality	Perception of the volunteers about the polymeric plate practicality.	2 weeks
General observations about the polymeric plate	General comments, suggestions and complaints of the volunteers about the polymeric plate.	2 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Principal Investigator: Fabiula BM dos Santos, Physio, University of Sao Paulo; Study Director: Valéria MC Elui, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 9, 2010
• Last Update Submitted That Met QC Criteria: April 8, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Thermotherapy; Therapeutic Hyperthermia; Castor Oil; Polymers
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: CEPHCFMRPUSP-11099