Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000834651
Ethics application status
Approved
Date submitted
18/07/2014
Date registered
6/08/2014
Date last updated
6/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Variation of the respiratory volumes in the asthmatic subject after the rotation sitting impulse technique of the dorso-lumbar junction.
Scientific title
Variation of the respiratory volumes in the asthmatic subject after the rotation sitting impulse technique of the dorso-lumbar junction.
Secondary ID [1] 285013 0
Nil known
Universal Trial Number (UTN)
U1111-1159-0943
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 292527 0
Condition category
Condition code
Alternative and Complementary Medicine 292831 292831 0 0
Other alternative and complementary medicine
Respiratory 292929 292929 0 0
Asthma
Physical Medicine / Rehabilitation 292930 292930 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic treatment: Rotation sitting impulse technique of the dorso-lumbar junction bilaterally
technique of high velocity, low amplitude in the dorso-lumbar junction known in osteopathy as "Fryette modified technique for dysfunction in T12 ERS." The aim of the technique is to increase lung volumes by restoring mobility at this level, where the diaphragmatic pillars are originated.
Subject Position: Sitting, hands placed like lift-off technique. Therapist position: forward to a side of the subject.
Contacts: pectoral contact on the outside of the upper side of the subject, locking the trunk. The previous hand contact on the back of the shoulder encircling the trunk of the subject and the elbow raised to rest his forehead. The back hand takes a pisiform contact ulnar border of the hand on the nested facet of T12
The technique is administered on a single occasion, but bilaterally
The duration of the tecnique is less than a minute (30 seconds approximately)
Intervention code [1] 289847 0
Treatment: Other
Comparator / control treatment
Placebo.
The same position of the subject and the osteopath, the same parameters and principles of the technique applied to the experimental group, but without impulse.
Control group
Placebo

Outcomes
Primary outcome [1] 292695 0
Possible variations of respiratory volumes FVC, FEV1, FEV1/FVC ratio and PEF assessed by spirometry, using a MIR Spirobank Registered Trademark USB spirometer.
Timepoint [1] 292695 0
Pre-intervention, 1 minute post-intervention, 30 minutes post-intervention and 1 week post-intervention.
Secondary outcome [1] 309512 0
Possible variations of MiniAQLQ quality of life questionnaire.
Timepoint [1] 309512 0
Pre-intervention and 1 week post-intervention.

Eligibility
Key inclusion criteria
Having diagnosed the disease "asthma" for over 1 year
Aged between 20 and 49 years inclusive
Sign the informed consent.
Do not submit any exclusion criteria
Minimum age
20 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
COPD
Lung Cancer
Emphysema
Pulmonary edema
Heart failure
Pulmonary hypertension
Smooth muscle disorders and / or striated
Surgical lung and / or chest
Use of inhaled beta 2 agonists in the 24 hours prior to the study
Rates of asthma medication in the last 6 weeks or during the study
Hospitalization for acute crisis, and / or oral corticosteroids in the last month or during the study
Anxiety
Depression
Respiratory infection in the last month
Osteopathic treatment in the last month
Osteopathic treatment for asthma in the last 5 years
Contraindication to performing maneuvers study: fractures and / or dislocations, tumors, infections, inflammatory rheumatism, birth defects, osteoporosis

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 method of allocation concealment used wwas central randomsation by computer.
Subjects were randomly assigned to study groups using a table of random numbers generated by a computer, once it was found that the subject met the inclusion and exclusion criteria for participation in the study.
6 sequences encoded characters (A, B) replacing the random numbers, in which A represents the experimental group and B represents control group were used. The randomization sequence was guarded at all times by the principal investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomisation table generated by a computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To calculate the sample size formula for estimating proportions was used. The study population was 63,566 subjects (estimated from prevalence data of 4.4% between the ages 18-44 years in Madrid population). An error of 13.5% and a confidence interval of 95% was assumed. The formula for calculating the sample size has the following mathematical expression:

k(2) * P *Q 1,96(2) * 0,5 * 0,5
n = --------------- = -------------------------- = 52,71 ˜ 52
e(2) 0,135(2)

where:
k = constant for 95% = 1.96
P = proportion of individuals that possess the property of the population = 0.5
Q = 1 - P = 1 to 0.5
e = MPE = 13.5%
Therefore, the appropriate sample size for the study was 52 subjects.

Statistical analysis was performed using SPSS version 19.0 program. There has been a statistical description of the bulk sample, and one each of the study groups. The Kormogorov-Smirnov test was used to verify whether or not data fit a normal distribution.
In the intragroup analysis, as proof of hypothesis testing for comparing scores pre-intervention and post-intervention Student t test for related samples was performed for both GE and GC. For the intergroup analysis, the Student t test for independent samples, where the differences between the post-intervention measures were contrasted minus pre-intervention between GE and GC measures. A confidence interval of 95%, so that is considered statistically significant values are those established as p <0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2014
Actual
8/01/2014
Date of last participant enrolment
Anticipated
Actual
26/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 6236 0
Spain
State/province [1] 6236 0
Madrid

Funding & Sponsors
Funding source category [1] 289624 0
Self funded/Unfunded
Name [1] 289624 0
David Nunez Fernandez
Country [1] 289624 0
Spain
Primary sponsor type
Other
Name
Escuela de Osteopatia de Madrid
Address
San Felix de Alcala Street, 4
28807 Alcala de Henares
Madrid
Country
Spain
Secondary sponsor category [1] 288312 0
None
Name [1] 288312 0
Address [1] 288312 0
Country [1] 288312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291366 0
Experimentation Ethics Committee of the University of Seville
Ethics committee address [1] 291366 0
Ethics committee country [1] 291366 0
Spain
Date submitted for ethics approval [1] 291366 0
20/10/2013
Approval date [1] 291366 0
29/11/2013
Ethics approval number [1] 291366 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 123 123 0 0
/AnzctrAttachments/366748-Questionnaire for evaluation by experimentation ethics committee of the University of Sevilla.doc
Attachments [2] 124 124 0 0
/AnzctrAttachments/366748-Report approved by the Ethics Committee for Experimentation of the University of Seville.doc
Attachments [3] 125 125 0 0
/AnzctrAttachments/366748-Blank clinical record forms.docx
Attachments [4] 126 126 0 0
/AnzctrAttachments/366748-Informed consent for study participation.doc
Attachments [5] 127 127 0 0
/AnzctrAttachments/366748-Data confidentiality.docx

Contacts
Principal investigator
Name 50050 0
Mr David Nunez Fernandez
Address 50050 0
Escuela de Osteopatia de Madrid
Avenida Estrasburgo II, no 77
28514 Nuevo Baztan
Madrid
Country 50050 0
Spain
Phone 50050 0
+34 669927288
Fax 50050 0
+ 34 91 8725532
Email 50050 0
[email protected]
Contact person for public queries
Name 50051 0
David Nunez Fernandez
Address 50051 0
David Nunez Fernandez
Escuela de Osteopatia de Madrid
Avenida Estrasburgo II, no 77
28514 Nuevo Baztan
Madrid
Country 50051 0
Spain
Phone 50051 0
+ 34 669927288
Fax 50051 0
+ 34 91 8725532
Email 50051 0
[email protected]
Contact person for scientific queries
Name 50052 0
David Nunez Fernandez
Address 50052 0
David Nunez Fernandez
Escuela de Osteopatia de Madrid
Avenida Estrasburgo II, no 77
28514 Nuevo Baztan
Madrid
Country 50052 0
Spain
Phone 50052 0
+ 34 669927288
Fax 50052 0
+ 34 91 8725532
Email 50052 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

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