Therapeutic HyperthermiaNCT01100541
Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
A study testing Polymeric plate in people with Therapeutic Hyperthermia and Thermotherapy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Hyperthermia, Thermotherapy, Polymers
- What is being tested?
- Polymeric plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good communication and comprehension
- Skin integrity
Who cannot join
- Reduced skin sensitivity
- Disturbance in the central nervous system
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Interunits postgraduate program in bioengineering
São Carlos, São Paulo, 13566-590
About this study
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.
Read the detailed description
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.
- Conditions
- Therapeutic Hyperthermia, Thermotherapy, Polymers
- Being tested
- Polymeric plate
- Keywords
- Therapeutic Hyperthermia, Thermotherapy, Polymers, Castor Oil
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymeric plateDevice
Also called PPDOM, PPDCO
Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.
| Study group | Role | What they receive |
|---|---|---|
| Polymeric plate characteristics | Experimental | Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics. Receives: Device: Polymeric plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the polymeric plate
Acceptance of the polymeric plate by the volunteers.
Measured: 2 weeks
Secondary outcomes (8)
Polymeric plate comfort
Perception of the volunteers about the comfort of the polimeric plate.
Measured: 2 weeks
Polymeric plate temperature
Perception of the volunteers about the polymeric plate temperature.
Measured: 2 weeks
Polymeric plate time of heat retention
Perception of the volunteers about the polymeric plate time of heat retention.
Measured: 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.
Measured: 2 weeks
Appearance of the polymeric plate
Perception of the volunteers about the appearence of the polymeric plate.
Measured: 2 weeks
Polymeric plate weight
Perception of the volunteers about the polymeric plate weight.
Measured: 2 weeks
Polymeric plate practicality
Perception of the volunteers about the polymeric plate practicality.
Measured: 2 weeks
General observations about the polymeric plate
General comments, suggestions and complaints of the volunteers about the polymeric plate.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic HyperthermiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Fabiula BM dos Santos, Physio, Principal investigator, University of Sao PauloValéria MC Elui, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100541
- Sponsor's protocol ID
- CEPHCFMRPUSP-11099
- Status last verified
- Apr 2010
- First submitted
- 6 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
- ClinicalTrials.gov ID
- NCT01100541
- Acronym / sponsor ID
- CEPHCFMRPUSP-11099
- Conditions
- Therapeutic Hyperthermia, Thermotherapy, Polymers
- Keywords
- Therapeutic Hyperthermia, Thermotherapy, Polymers, Castor Oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polymeric plate characteristics | Experimental | Device: Polymeric plateEvaluation, in the volunteers viewpoint, of the polymeric plate characteristics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good communication and comprehension
- Skin integrity
Key exclusion criteria (2 listed)
- Reduced skin sensitivity
- Disturbance in the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymeric plateAlso: PPDOM, PPDCOApplication of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature. | Device | Polymeric plate characteristics |
Primary outcome
Acceptance of the polymeric plate
Time frame: 2 weeks
Acceptance of the polymeric plate by the volunteers.
8 secondary outcomes
Polymeric plate comfort
Time frame: 2 weeks
Polymeric plate temperature
Time frame: 2 weeks
Polymeric plate time of heat retention
Time frame: 2 weeks
Sensation on the superficial touch of the polymeric plate
Time frame: 2 weeks
Appearance of the polymeric plate
Time frame: 2 weeks
Polymeric plate weight
Time frame: 2 weeks
Polymeric plate practicality
Time frame: 2 weeks
General observations about the polymeric plate
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiula BM dos Santos, Physio principal investigator
University of Sao Paulo
Valéria MC Elui, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymeric plate in people with Therapeutic Hyperthermia and Thermotherapy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of the polymeric plate (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010.