Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000023358
Ethics application status
Approved
Date submitted
13/01/2008
Date registered
16/01/2008
Date last updated
16/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of the Neuro Postural Optimization therapy with Conveyer of modulating radiance to treat Dysfunctional Patellar Misalignment at the passage from the supine to the sitting position and vice versa in patients with a negative anamnesis for muscular or bone-relevant trauma.
Scientific title
Evaluation of the effectiveness of the Neuro Postural Optimization therapy with Conveyer of modulating radiance to treat Functional Dysmetria
Universal Trial Number (UTN)
Trial acronym
ONP1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional patellar misalignment 2707 0
Condition category
Condition code
Musculoskeletal 2828 2828 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study that has involved in eight years 3700 subjects, we have evaluated the effectiveness of the Neuro Postural Optimization (NPO) therapy with Conveyer of modulating radiance (CMR) to treat Functional Dysmetria
The Functional Dysmetria (FD) determined by a neuropsychomotor attitude deriving from the adaptation at environmental stress.
The NPO is a protocol with CMR finalized to correct FD. Involves the application of a probe of the CMR on one specific point of the auricular pavilion for an activation time of roughly 500 mms. The CMR is a biomedical radiofrequency instrument.
The intervention comprises three phases:
Observation of FD carried out with subject in supine position, in sitting position, during the passage from supine to sitting position and vice versa. So as to quantify misalignment and then FD, we employed a not invasive calibre that we have specifically devised, with 1-mm-resolution.
Treatment NPO with CMR therapy.
Observation of the effect of NPO on FD carried out with subject in supine position, in sitting position, during the passage from supine to sitting position and vice versa. Assessment, at baseline and immediately at the end of treatment, after a two months, after one year.
Each observation takes about three minutes, the NPO treatment with CMR therapy takes about one minute.
Intervention code [1] 2445 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3712 0
The observation of the stable disappearance of Functional Dysmetria
Timepoint [1] 3712 0
At the end of treatment, after a two months, after one year.
Secondary outcome [1] 6262 0
The measurement of the stable disappearance of Functional Dysmetria we employed a not invasive calibre that we have specifically devised, with 1-mm-resolution, named Dismetrometro.
Timepoint [1] 6262 0
At the end of treatment, after a two months, after one year.

Eligibility
Key inclusion criteria
Healthy subjects, with a negative anamnesis for muscular or bone-relevant trauma and patologies during the last 2 years
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects, with positive anamnesis for muscular or bone-relevant trauma in the last 2 years. Congenital malformation and other musculoskeletal or neurologically-known pathologies

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3700
Accrual to date
Final
Recruitment outside Australia
Country [1] 732 0
Italy
State/province [1] 732 0

Funding & Sponsors
Funding source category [1] 2960 0
Charities/Societies/Foundations
Name [1] 2960 0
Istituto Rinaldi Fontani
Country [1] 2960 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2671 0
Charities/Societies/Foundations
Name [1] 2671 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2671 0
Via Nazionale 23 50123 Firenze
Country [1] 2671 0
Italy
Other collaborator category [1] 146 0
University
Name [1] 146 0
University of Firenze - Department of Public Medicine - Occupational Health - Master of Second Level Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 146 0
Largo Palagi 1 - 50139 Firenze
Country [1] 146 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4907 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Ethics committee address [1] 4907 0
Via Nazionale 23 50123 Firenze
Ethics committee country [1] 4907 0
Italy
Date submitted for ethics approval [1] 4907 0
Approval date [1] 4907 0
Ethics approval number [1] 4907 0

Summary
Brief summary
Slight somatic differences, when not due to specific causes, prove the existence of Fluctuating Asymmetry (FA). FAs are defined as a casual loss of perfect symmetry, highlighted at level of symmetrical body segments and caused by environmental stressors. In this study that has involved in eight years 3700 subjects, we have highlighted the presence of asymmetry both in tonic and phasic activation of symmetrical muscular groups and its stable disappearance after the Neuro Postural Optimization. This asymmetrical activation named Functional Dysmetria (FD). We might assume that FD is determined by a neuropsychomotor attitude deriving from the adaptation at environmental stress, as observed for FAs.
The Neuro Postural Optimization is a protocol with Conveyer of Modulating Radiance finalized to correct FD. Involves the application of a probe of the CMR on one specific point of the auricular pavilion for an activation time of roughly 500 mms. The CMR is a biomedical radiofrequency instrument.
The intervention comprises three phases:
Observation of FD carried out with subject in supine position, in sitting position, during the passage from supine to sitting position and vice versa. So as to quantify misalignment and then FD, we employed a not invasive calibre that we have specifically devised, with 1-mm-resolution.
Treatment NPO with CMR therapy.
Observation of the effect of NPO on FD carried out with subject in supine position, in sitting position, during the passage from supine to sitting position and vice versa. Assessment, at baseline and immediately at the end of treatment, after a two months, after one year.
In all subjects studied we have observed the stable disappearance of the functional Dysmetria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28293 0
Address 28293 0
Country 28293 0
Phone 28293 0
Fax 28293 0
Email 28293 0
Contact person for public queries
Name 11450 0
Vania Fontani M.D.
Address 11450 0
Via Nazionale 23 50123 Firenze
Country 11450 0
Italy
Phone 11450 0
+39 055 290307
Fax 11450 0
Email 11450 0
vfontani@irf.it
Contact person for scientific queries
Name 2378 0
Salvatore Rinaldi M.D.
Address 2378 0
Via Nazionale 23 50123 Firenze
Country 2378 0
Italy
Phone 2378 0
+39 055 290307
Fax 2378 0
Email 2378 0
srinaldi@irf.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRadioelectric asymmetric stimulation of tissues as treatment for post-traumatic injury symptoms2011https://doi.org/10.2147/ijgm.s24296
N.B. These documents automatically identified may not have been verified by the study sponsor.