Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01100541
First received: April 6, 2010
Last updated: April 8, 2010
Last verified: April 2010
  Purpose

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 Intervention
Therapeutic Hyperthermia
Thermotherapy
Polymers
Device: Polymeric plate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Acceptance of the polymeric plate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Acceptance of the polymeric plate by the volunteers.


Secondary Outcome Measures:
  • Polymeric plate comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Perception of the volunteers about the comfort of the polimeric plate.

  • Polymeric plate temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Perception of the volunteers about the polymeric plate temperature.

  • Polymeric plate time of heat retention [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.

  • Appearance of the polymeric plate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Perception of the volunteers about the appearence of the polymeric plate.

  • Polymeric plate weight [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Perception of the volunteers about the polymeric plate weight.

  • Polymeric plate practicality [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Perception of the volunteers about the polymeric plate practicality.

  • General observations about the polymeric plate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    General comments, suggestions and complaints of the volunteers about the polymeric plate.


Enrollment: 30
Study Start Date: February 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good communication and comprehension
  • Skin integrity

Exclusion Criteria:

  • Reduced skin sensitivity
  • Disturbance in the central nervous system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100541

Locations
Brazil
Interunits postgraduate program in bioengineering
Sao Carlos, SP, Brazil, 13566-590
Sponsors and Collaborators
University of Sao Paulo
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
  More Information

Additional Information:
No publications provided

Responsible Party: Fabiula Barbosa Machado dos Santos, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01100541     History of Changes
Other Study ID Numbers: CEPHCFMRPUSP-11099
Study First Received: April 6, 2010
Last Updated: April 8, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Therapeutic Hyperthermia
Thermotherapy
Polymers
Castor Oil

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Castor Oil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014