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CompletedNCT02975531Updated Nov 29, 2016

Simulator of Pompage Technique for Physiotherapists

An interventional study of Simulator's construction and Model Features in Musculoskeletal Pain and Contracture, sponsored by University of Mogi das Cruzes. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by University of Mogi das Cruzes · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Musculoskeletal Pain
  • Contracture

Keywords

  • Pompage
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 72 is close to the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

University of Mogi das Cruzes is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • report pain in the cervical region (GT and VF)
  • irritations in the cervical region (GT and VF)
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Simulator's construction

    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.

    Other: Simulator's construction

  • Experimental
    Model Features

    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.

    Other: Model Features

  • Experimental
    Parameterization technique

    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.

    Other: Parameterization technique

  • Experimental
    Simulator training

    Twenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training.

    Other: Simulator training

  • Experimental
    Training Evaluation

    A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.

    Other: Training Evaluation

Interventions

  • OtherSimulator's construction

    Model to build the mold for the simulator

    Also known as: VF

  • OtherModel Features

    Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.

    Also known as: GT

  • OtherParameterization technique

    Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.

    Also known as: GP

  • OtherSimulator training

    Training of pompage technique using the simulator.

    Also known as: GE

  • OtherTraining Evaluation

    Evaluation of volunteers from GE group before and after training with the simulator.

    Also known as: VE

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 days

  2. Pressure

    The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.

    Time frame: 5 days

Secondary outcomes

  1. Cytometry neck

    The cytometry neck (cm) of the volunteers VF and GT was measure to validated the simulator.

    Time frame: 1 minute

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02975531
Lead sponsor
University of Mogi das Cruzes
Responsible party
Annie France Frère Slaets (PhD, University of Mogi das Cruzes) — Principal investigator
First posted
Nov 29, 2016
Start date
Feb 2008
Primary completion
Apr 2008
Completion
Feb 2012
Last update
Nov 29, 2016

Study contacts

Annie F. Frère, PhD
principal investigator · University of Mogi das Cruzes

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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