NCT02975531

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

March 9, 2016

Last Update Submit

November 28, 2016

Conditions

Keywords

Pompage

Outcome Measures

Primary Outcomes (2)

  • 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.

    5 days

  • Pressure

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

    5 days

Secondary Outcomes (1)

  • Cytometry neck

    1 minute

Study Arms (5)

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.

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.

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.

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.

Other: Simulator training

Training Evaluation

EXPERIMENTAL

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

Other: Training Evaluation

Interventions

Model to build the mold for the simulator

Also known as: VF
Simulator's construction

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

Also known as: GT
Model Features

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

Also known as: GP
Parameterization technique

Training of pompage technique using the simulator.

Also known as: GE
Simulator training

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

Also known as: VE
Training Evaluation

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal PainContracture

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint Diseases

Study Officials

  • Annie F. Frère, PhD

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 9, 2016

First Posted

November 29, 2016

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

February 1, 2012

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share