Skip to main content
OpenTrials
Completed

NCT Number: NCT01100541

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Therapeutic Hyperthermia Body Temperature Changes Heat Stress Disorders Hyperthermia Pathological Conditions, Signs and Symptoms Polymers Signs and Symptoms Thermotherapy Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interunits postgraduate program in bioengineering

São Carlos, São Paulo, 13566-590, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good communication and comprehension
  • Skin integrity

Exclusion criteria

  • Reduced skin sensitivity
  • Disturbance in the central nervous system

Treatment and study plan

Polymeric plate

Device

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

Primary outcomes

  1. Acceptance of the polymeric plate

    Time frame: 2 weeks

    Acceptance of the polymeric plate by the volunteers.

Secondary outcomes

  1. Polymeric plate comfort

    Time frame: 2 weeks

    Perception of the volunteers about the comfort of the polimeric plate.

  2. Polymeric plate temperature

    Time frame: 2 weeks

    Perception of the volunteers about the polymeric plate temperature.

  3. Polymeric plate time of heat retention

    Time frame: 2 weeks

    Perception of the volunteers about the polymeric plate time of heat retention.

  4. 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.

  5. Appearance of the polymeric plate

    Time frame: 2 weeks

    Perception of the volunteers about the appearence of the polymeric plate.

  6. Polymeric plate weight

    Time frame: 2 weeks

    Perception of the volunteers about the polymeric plate weight.

  7. Polymeric plate practicality

    Time frame: 2 weeks

    Perception of the volunteers about the polymeric plate practicality.

  8. General observations about the polymeric plate

    Time frame: 2 weeks

    General comments, suggestions and complaints of the volunteers about the polymeric plate.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2010
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.