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Trial registered on ANZCTR


Registration number
ACTRN12607000463471
Ethics application status
Approved
Date submitted
7/09/2007
Date registered
13/09/2007
Date last updated
13/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in patients with stress-related pychophysiologic sensations.
Scientific title
Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in patients with stress-related psychophysiologic sensations. A randomised controlled trial to evaluate the effectiveness.
Universal Trial Number (UTN)
Trial acronym
CRMTPH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress related psychophysiologic sensations. 2344 0
Condition category
Condition code
Mental Health 2448 2448 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises: A cycle of Neuro Psycho Physical Optimization (NPPO) with Conveyer of Modulating Radiance (CMR therapy). The CMR is a biomedical radiofrequency instrument. The protocol used, called Neuro Psycho Physical Optimization (ONPF), involves the application of a probe of the CMR on specific points of the auricular pavilion for an activation time of roughly 500 mms. The ONPF protocol is activated in a precise sequence on seven auricular points. The protocol envisages 18 sessions of ONPF treatment on alternating days, for eight (8)weeks.
Assessment, at baseline and at the end of treatment, with Psychological Stress Measure Test (validated in Italian).
Intervention code [1] 2064 0
Treatment: Devices
Comparator / control treatment
The reduction of the subjective perception of stress and stress-related pychophysiologic sensations after an NPPO cycle with CMR device, shows significant results (P<.05), respect to a control group that was treated with inactivated CMR.
Control group
Placebo

Outcomes
Primary outcome [1] 3348 0
To test with Psychological Stress Measure if the use of the Conveyer of Modulating Radiance (CMR) - is effective in reducing the subjective perception of stress and stress-related pychophysiologic sensations.
Timepoint [1] 3348 0
At time zero and after the cycle of therapy, around two months.
Secondary outcome [1] 5563 0
Wellbeing - Neuro Psycho Physical Optimization
Timepoint [1] 5563 0
At time zero and after the cycle of therapy, around two months.

Eligibility
Key inclusion criteria
Subjects with Psychological Stress Measure Test positive for psychophysiologic sensations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with psychophysiologic symptoms in psychiatric - organic diseases or aged less than 18 years of age were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects, concealed way, was allocated randomly to treatment or control group by an external operator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by an external operator - computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 599 0
Italy
State/province [1] 599 0

Funding & Sponsors
Funding source category [1] 2600 0
Charities/Societies/Foundations
Name [1] 2600 0
Istituto Rinaldi Fontani
Country [1] 2600 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2352 0
Charities/Societies/Foundations
Name [1] 2352 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2352 0
Via Nazionale 23 50123 Firenze
Country [1] 2352 0
Italy
Other collaborator category [1] 35 0
University
Name [1] 35 0
University of Firenze - Department of Public Medicine - Occupational Health - Master of Second Level Neuro Psycho Physical Optimization and CRM Therapy
Address [1] 35 0
Largo Palagi 1 - 50139 Firenze
Country [1] 35 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4521 0
Societa Di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Ethics committee address [1] 4521 0
Via Nazionale 23 50123 Firenze
Ethics committee country [1] 4521 0
Italy
Date submitted for ethics approval [1] 4521 0
09/11/2000
Approval date [1] 4521 0
09/11/2000
Ethics approval number [1] 4521 0

Summary
Brief summary
A high proportion of patients with emotional problems present only psychophysiologic sensations indicative of general distress. These symptoms are medically unexplained and difficult to treat.
In this study we have use the Psychological Stress Misure
validated in Italian) to test the effectiveness of Neuro Psycho Physical Optimization (NPPO) with Conveyer of Modulating Radiance - CMR Therapy in reducing the subjective perception of stress and stress-related psychophysiologic sensations.
The reduction of the symptomatology of stress and stress-related psychophysiologic sensations after an NPPO cycle with CMR therapy shows significant results (P<.05) with respect to a control group that was treated with inactivated CRM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28037 0
Address 28037 0
Country 28037 0
Phone 28037 0
Fax 28037 0
Email 28037 0
Contact person for public queries
Name 11194 0
Fontani Vania M.D.
Address 11194 0
Via Nazionale 23 50123 Firenze
Country 11194 0
Italy
Phone 11194 0
+39 055 290307
Fax 11194 0
Email 11194 0
vfontani@irf.it
Contact person for scientific queries
Name 2122 0
Salvatore Rinaldi M.D.
Address 2122 0
Via Nazionale 23 50123 Firenze
Country 2122 0
Italy
Phone 2122 0
+39 055 290307
Fax 2122 0
Email 2122 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
EmbaseStress-related psycho-physiological disorders: Randomized single blind placebo controlled naturalistic study of psychometric evaluation using a radio electric asymmetric treatment.2011https://dx.doi.org/10.1186/1477-7525-9-54
N.B. These documents automatically identified may not have been verified by the study sponsor.