Musculoskeletal PainNCT02975531
Simulator of Pompage Technique for Physiotherapists
A study testing Simulator's construction, Model Features and Parameterization technique in people with Musculoskeletal Pain and Contracture, run by University of Mogi das Cruzes.
Trial summary
Parameterize the Pompage technique with an anatomical model cervical region to simulate specific procedures. Quantify the times, displacements, and facilitate the training of students and professional of physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Contracture
- What is being tested?
- Simulator's construction, Model Features and Parameterization technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Feb 2012
- 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
- no history of cervical trauma (GT and VF)
- Do not have dermatitis in the cervical region (GT and VF)
- recurrent migraines (GT and VF)
- no prior knowledge of Pompage technique (GE).
- minimum 5 years experience of applying the Pompage technique (GP and VE).
Who cannot join
- report pain in the cervical region (GT and VF)
- irritations in the cervical region (GT and VF)
About this study
Official title: Simulator of Pompage Technique for Education and Training of Physiotherapists
Parameterize the Pompage technique with an anatomical model cervical region to simulate specific procedures. Quantify the times, displacements, and facilitate the training of students and professional of physical therapy.
Read the detailed description
Manual techniques are taught and trained with practical demonstration without technology support to measure them, so they are difficult to reproduce. This difficulty increases in Pompage technique because the student is not able to estimate the displacement on the skin. In this research, to parameterize and train the technique was developed and validated an anatomical model of the cervical region, with silicone and latex rubber. The anatomical model simulates the soft tissues and a plastic resin structure represents the cervical spine bone. An optical sensor was used to measure the displacements performed on simulated skin versus time. The Likert scale was used for assessing the similarity of the anatomical model relative to the size, shape, texture, elasticity and displacement of the skin as well as the curvature of the cervical spine. Five experienced professionals (GP) in the technical performed five series of Pompage technique. With the mean of data collected were determined benchmarks for technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers (GE) with no experience performed the Pompage technique, with the anatomical model following the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.
- Conditions
- Musculoskeletal Pain, Contracture
- Being tested
- Simulator's construction, Model Features, Parameterization technique, Simulator training, Training Evaluation
- Keywords
- Pompage
- Medical subject headings
- Musculoskeletal Pain, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator's constructionOther
Also called VF
Model to build the mold for the simulator
Model FeaturesOther
Also called GT
Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.
Parameterization techniqueOther
Also called GP
Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.
Simulator trainingOther
Also called GE
Training of pompage technique using the simulator.
Training EvaluationOther
Also called VE
Evaluation of volunteers from GE group before and after training with the simulator.
| Study group | Role | What they receive |
|---|---|---|
| Simulator's construction | Experimental | To build the simulator was selected a volunteer (VF) as a model. This volunteer had no complaints of pain or trauma to the cervical region. This region was used to collect the displacement of the skin and cytometry neck. Receives: Other: Simulator's construction |
| Model Features | Experimental | Thirty-nine volunteers (GT) were selected men and women aged over 18 years without history of trauma in the cervical region in order to determine the characteristics of the model: skin elasticity and cirtometry neck. Receives: Other: Model Features |
| Parameterization technique | Experimental | Five physiotherapists (GP) with at least 5 years of experience in the technique were selected to perform the technique on the simulator and complete a questionnaire in order to evaluate the texture and skin elasticity, the curvature and size of the cervical spine format. They scored these items from the Likert scale. After evaluation they used the simulator to generate a standard guide training. Receives: Other: Parameterization technique |
| Simulator training | Experimental | Twenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training. Receives: Other: Simulator training |
| Training Evaluation | Experimental | A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator. Receives: Other: Training Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of the skin
The displacement of the skin (mm) of the volunteers VF and GT was measured to validated the simulator. The volunteers GE used the simulator and the displacement of the skin of simulator was measured during the Pompage technique.
Measured: 5 days
Pressure
The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.
Measured: 5 days
Secondary outcomes (1)
Cytometry neck
The cytometry neck (cm) of the volunteers VF and GT was measure to validated the simulator.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annie France Frère Slaets, University of Mogi das Cruzes
- Investigators
- Annie F. Frère, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975531
- Sponsor's protocol ID
- 0121.0.237.00007
- Status last verified
- Nov 2016
- First submitted
- 9 Mar 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulator of Pompage Technique for Education and Training of Physiotherapists
- ClinicalTrials.gov ID
- NCT02975531
- Acronym / sponsor ID
- 0121.0.237.00007
- Conditions
- Musculoskeletal Pain, Contracture
- Keywords
- Pompage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Nov 2016 (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.
Parameterize the Pompage technique with an anatomical model cervical region to simulate specific procedures. Quantify the times, displacements, and facilitate the training of students and professional of physical therapy.
Detailed description
Manual techniques are taught and trained with practical demonstration without technology support to measure them, so they are difficult to reproduce. This difficulty increases in Pompage technique because the student is not able to estimate the displacement on the skin. In this research, to parameterize and train the technique was developed and validated an anatomical model of the cervical region, with silicone and latex rubber. The anatomical model simulates the soft tissues and a plastic resin structure represents the cervical spine bone. An optical sensor was used to measure the displacements performed on simulated skin versus time. The Likert scale was used for assessing the similarity of the anatomical model relative to the size, shape, texture, elasticity and displacement of the skin as well as the curvature of the cervical spine. Five experienced professionals (GP) in the technical performed five series of Pompage technique. With the mean of data collected were determined benchmarks for technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers (GE) with no experience performed the Pompage technique, with the anatomical model following the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Simulator's construction | Experimental | Other: Simulator's constructionTo build the simulator was selected a volunteer (VF) as a model. This volunteer had no complaints of pain or trauma to the cervical region. This region was used to collect the displacement of the skin and cytometry neck. |
| Model Features | Experimental | Other: Model FeaturesThirty-nine volunteers (GT) were selected men and women aged over 18 years without history of trauma in the cervical region in order to determine the characteristics of the model: skin elasticity and cirtometry neck. |
| Parameterization technique | Experimental | Other: Parameterization techniqueFive physiotherapists (GP) with at least 5 years of experience in the technique were selected to perform the technique on the simulator and complete a questionnaire in order to evaluate the texture and skin elasticity, the curvature and size of the cervical spine format. They scored these items from the Likert scale. After evaluation they used the simulator to generate a standard guide training. |
| Simulator training | Experimental | Other: Simulator trainingTwenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training. |
| Training Evaluation | Experimental | Other: Training EvaluationA physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- no history of cervical trauma (GT and VF)
- Do not have dermatitis in the cervical region (GT and VF)
- recurrent migraines (GT and VF)
- no prior knowledge of Pompage technique (GE).
- minimum 5 years experience of applying the Pompage technique (GP and VE).
Key exclusion criteria (2 listed)
- report pain in the cervical region (GT and VF)
- irritations in the cervical region (GT and VF)
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 |
|---|---|---|
| Simulator's constructionAlso: VFModel to build the mold for the simulator | Other | Simulator's construction |
| Model FeaturesAlso: GTVolunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator. | Other | Model Features |
| Parameterization techniqueAlso: GPEvaluation of the simulator features and parameterization of the Pompage technique in the simulator. | Other | Parameterization technique |
| Simulator trainingAlso: GETraining of pompage technique using the simulator. | Other | Simulator training |
| Training EvaluationAlso: VEEvaluation of volunteers from GE group before and after training with the simulator. | Other | Training Evaluation |
Primary outcome
Displacement of the skin
Time frame: 5 days
The displacement of the skin (mm) of the volunteers VF and GT was measured to validated the simulator. The volunteers GE used the simulator and the displacement of the skin of simulator was measured during the Pompage technique.
Pressure
Time frame: 5 days
The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.
1 secondary outcome
Cytometry neck
Time frame: 1 minute
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 29 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
Annie F. Frère, PhD principal investigator
University of Mogi das Cruzes
Questions about this trial
What is this clinical trial studying?
A study testing Simulator's construction, Model Features and Parameterization technique in people with Musculoskeletal Pain and Contracture, run by University of Mogi das Cruzes.
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 5 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Displacement of the skin (time frame: 5 days). The study lists 2 primary outcomes in all. 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 29 Nov 2016.