NCT01100541

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
Last Updated

April 9, 2010

Status Verified

April 1, 2010

Enrollment Period

Same day

First QC Date

April 6, 2010

Last Update Submit

April 8, 2010

Conditions

Therapeutic HyperthermiaThermotherapyPolymers

Keywords

Therapeutic HyperthermiaThermotherapyPolymersCastor Oil

Outcome Measures

Primary Outcomes (1)

  • Acceptance of the polymeric plate

    Acceptance of the polymeric plate by the volunteers.

    2 weeks

Secondary Outcomes (8)

  • Polymeric plate comfort

    2 weeks

  • Polymeric plate temperature

    2 weeks

  • Polymeric plate time of heat retention

    2 weeks

  • Sensation on the superficial touch of the polymeric plate

    2 weeks

  • Appearance of the polymeric plate

    2 weeks

  • +3 more secondary outcomes

Study Arms (1)

Polymeric plate characteristics

EXPERIMENTAL

Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics.

Device: Polymeric plate

Interventions

Polymeric plateDEVICE

Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.

Also known as: PPDOM, PPDCO
Polymeric plate characteristics

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good communication and comprehension
  • Skin integrity

You may not qualify if:

  • Reduced skin sensitivity
  • Disturbance in the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interunits postgraduate program in bioengineering

São Carlos, São Paulo, 13566-590, Brazil

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Fabiula BM dos Santos, Physio

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Valéria MC Elui, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 9, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 9, 2010

Record last verified: 2010-04

Locations

BR(1)