Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000529448
Ethics application status
Approved
Date submitted
11/10/2007
Date registered
16/10/2007
Date last updated
16/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double blinded evaluation of the effectiveness of Neuro Psycho Physical Optimization with Conveyer of Modulating Radiance (CMR) in stress-related disorders, assessed with Psychological Stress Measure Test
Scientific title
A double blinded randomised trial to evaluate 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 symptoms, assessed with Psychological Stress Measure Test
Universal Trial Number (UTN)
Trial acronym
CRMTMSPDB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perception of stress, and stress-related symptoms. 2441 0
Condition category
Condition code
Mental Health 2544 2544 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 immediately at the end of treatment, with Psychological Stress Measure Test (validated in Italian)
Intervention code [1] 2170 0
Treatment: Devices
Comparator / control treatment
The reduction of the subjective perception of stress and stress-related symptoms, after an NPPO cycle with CMR device, shows significant results (P<.05), respect to a control group that was treated with placebo (inactivated CMR)for 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 3449 0
To test if the use of the Conveyer of Modulating Radiance (CMR) - is effective in reducing the subjective perception of stress, and stress-related symptoms, assessed with Psychological Stress Measure Test
Timepoint [1] 3449 0
At time zero and immediatly after the therapy cycle.
Secondary outcome [1] 5738 0
Wellbeing - Neuro Psycho Physical Optimization.
Timepoint [1] 5738 0
At time zero and immediatly after the therapy cycle.

Eligibility
Key inclusion criteria
Subjects over 18 years old, with any type of stress-related symptoms, with Psychological Stress Measure Test (PSM Test) total score over 50 points.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with psychiatric symptoms-pathologies, drugs dependence 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 (unawared), 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 - computerized sequence generation at the reception desk
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The CMR device will be indistinguishable and only the external operator that will manage the computer program of randomization and assignment of the single subjects to the various therapy rooms, where to effect the therapy, will know of it.
These information will be kept in closed envelope and actually sealed by the same external operator at the end of the study. For such motive the recruited subjects, in randomised way, will be divided in four groups. The assignment to the four groups and to the therapy rooms will be produced by an external operator to our Institute through such a computerized procedure, to produce a relationship random among the two groups of around 3 to 1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 621 0
Italy
State/province [1] 621 0

Funding & Sponsors
Funding source category [1] 2691 0
Charities/Societies/Foundations
Name [1] 2691 0
Istituto Rinaldi Fontani
Country [1] 2691 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2435 0
Charities/Societies/Foundations
Name [1] 2435 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2435 0
Via Nazionale 23 50123 Firenze
Country [1] 2435 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4611 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Ethics committee address [1] 4611 0
Via Nazionale 23 50123 Firenze
Ethics committee country [1] 4611 0
Italy
Date submitted for ethics approval [1] 4611 0
Approval date [1] 4611 0
04/06/2000
Ethics approval number [1] 4611 0

Summary
Brief summary
In this trial we have used the Psychological Stress Measure Test (validated in Italian) to assess 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 symptoms. The reduction of the perception of subjective stress and stress-related symptoms after a NPPO cycle with CMR therapy shows significant results (P<.05) with respect to a control group that was treated with placebo (inactivated CMR).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28104 0
Address 28104 0
Country 28104 0
Phone 28104 0
Fax 28104 0
Email 28104 0
Contact person for public queries
Name 11261 0
Vania Fontani M.D.
Address 11261 0
Via Nazionale 23 50123 Firenze
Country 11261 0
Italy
Phone 11261 0
+39 055 290307
Fax 11261 0
Email 11261 0
[email protected]
Contact person for scientific queries
Name 2189 0
Salvatore Rinaldi M.D
Address 2189 0
Via Nazionale 23 50123 Firenze
Country 2189 0
Italy
Phone 2189 0
+39 055 290307
Fax 2189 0
Email 2189 0
[email protected]

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
EmbasePsychometric evaluation of a radio electric auricular treatment for stress related disorders: A double-blinded, placebo-controlled controlled pilot study.2010https://dx.doi.org/10.1186/1477-7525-8-31
N.B. These documents automatically identified may not have been verified by the study sponsor.