Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001146987
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
2/11/2011
Date last updated
3/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Spirometric variations before and after lung technique manipulation in smokers
Scientific title
The effect of visceral manipulation on respiratory function in smokers
Secondary ID [1] 273191 0
Nil
Universal Trial Number (UTN)
U1111-1125-1626
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smokers 278941 0
Respiratory function 279059 0
Condition category
Condition code
Respiratory 279121 279121 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 279124 279124 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we make a visceral manipulation (during three respiratory cycles) and evaluating the influence about respiratory function inmediatly after the technique.
The manipulation consist to make presure in the base of the lung after a brief, trying to make a stretch of the pleura.
We do it once in every participant.
Intervention code [1] 269517 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 279767 0
changes in spirometric values (FVC,FEV1,PEF,FEF25-75%)
Timepoint [1] 279767 0
inmediatly after technique
Secondary outcome [1] 294395 0
changes in spirometric values from men against women
Timepoint [1] 294395 0
inmediatly after technique
Secondary outcome [2] 294396 0
changes in spirometric values in people with abdominal surgery
Timepoint [2] 294396 0
inmediatly after technique

Eligibility
Key inclusion criteria
Sign the informed consent
Smokers from more than two years
Over 18 years old and under 50 years old
Smoking more than ten cigarettes a day

(abdominal surgery isn´t a inclusion criteria, but there´s no problem if someone is included because we´ll study the changes in this participants againts that one who don´t have any abdominal surgery)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Spirometry contraindications
Osteopathy contraindications
Osteopathy treatments in the last month

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 3906 0
Spain
State/province [1] 3906 0

Funding & Sponsors
Funding source category [1] 284104 0
Self funded/Unfunded
Name [1] 284104 0
Aitor Bano Alcaraz
Country [1] 284104 0
Spain
Primary sponsor type
Individual
Name
Aitor Bano Alcaraz
Address
Paseo FLORENCIA,23 30012 MURCIA
Country
Spain
Secondary sponsor category [1] 269066 0
None
Name [1] 269066 0
Address [1] 269066 0
Country [1] 269066 0
Other collaborator category [1] 252311 0
Individual
Name [1] 252311 0
Manuel Peinado Asensio
Address [1] 252311 0
calle Erudito Orellana, 13 puerta 3, 46008, Valencia
Country [1] 252311 0
Spain
Other collaborator category [2] 252312 0
Individual
Name [2] 252312 0
Angel Oliva Pascual-Vaca
Address [2] 252312 0
C/ Goleta ,6
41740 Lebrija (Sevilla)
Country [2] 252312 0
Spain
Other collaborator category [3] 252313 0
Individual
Name [3] 252313 0
Cleofas Rodriguez Blanco
Address [3] 252313 0
C/ Otono 35
41710 Utrera (Sevilla)
Country [3] 252313 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272054 0
Comite Etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 272054 0
Comite de Etica. Pabellon de Brasil. Universidad de Sevilla. Paseo de las Delicias s/n 41013 SEVILLA
Ethics committee country [1] 272054 0
Spain
Date submitted for ethics approval [1] 272054 0
15/10/2011
Approval date [1] 272054 0
27/10/2011
Ethics approval number [1] 272054 0

Summary
Brief summary
This study aims to assess whether osteopathic lung manipulative technique in smokers causes changes in spirometric values.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33257 0
Address 33257 0
Country 33257 0
Phone 33257 0
Fax 33257 0
Email 33257 0
Contact person for public queries
Name 16504 0
Aitor Bano Alcaraz
Address 16504 0
paseo Florencia,23 3-A, 30012 Murcia
Country 16504 0
Spain
Phone 16504 0
+34686539121
Fax 16504 0
Email 16504 0
osteopatiarondasur@hotmail.com
Contact person for scientific queries
Name 7432 0
Aitor Bano Alcaraz
Address 7432 0
paseo Florencia,23 3-A, 30012 Murcia
Country 7432 0
Spain
Phone 7432 0
+34686539121
Fax 7432 0
Email 7432 0
osteopatiarondasur@hotmail.com

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
No additional documents have been identified.