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Trial registered on ANZCTR
Registration number
ACTRN12611001145998
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
2/11/2011
Date last updated
2/11/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of spinal manipulation on respiratory function in smokers
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Scientific title
Will T4 Dog technique produce changes in spirometry values in smokers
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Secondary ID [1]
273273
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Nil
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Universal Trial Number (UTN)
U1111-1125-4381
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
smokers
279036
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Respiratory function
279058
0
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Condition category
Condition code
Respiratory
279223
279223
0
0
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Other respiratory disorders / diseases
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Physical Medicine / Rehabilitation
279224
279224
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
we make a osteopathic manipulation once in T4 trying to stimulate the orthosympathetic innervation and evaluating the influence about respiratory function inmediatly after the technique.
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Intervention code [1]
269616
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Treatment: Other
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Comparator / control treatment
no treatment
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Control group
Active
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Outcomes
Primary outcome [1]
279854
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changes in spirometric values (FVC, FEV1, PEF, FEF25-75%)
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Assessment method [1]
279854
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Timepoint [1]
279854
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inmediatly after the technique
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Secondary outcome [1]
294586
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change in spirometric values from men against women
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Assessment method [1]
294586
0
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Timepoint [1]
294586
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inmediatly after the technique
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Secondary outcome [2]
294587
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change in spirometric values by age
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Assessment method [2]
294587
0
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Timepoint [2]
294587
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inmediatly after the technique
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Secondary outcome [3]
294588
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changes in spirometric values according to number of cigarettes smoked per day
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Assessment method [3]
294588
0
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Timepoint [3]
294588
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inmediatly after the technique
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Eligibility
Key inclusion criteria
Sign the informed consent
Smokers from more than two years
Over 18 years old and under 50 years old
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Spirometry contraindications
Osteopathy contraindications
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3930
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Spain
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State/province [1]
3930
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Murcia
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Funding & Sponsors
Funding source category [1]
284105
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Self funded/Unfunded
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Name [1]
284105
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Aitor Bano Alcaraz
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Address [1]
284105
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Paseo FLORENCIA,23 30012 MURCIA
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Country [1]
284105
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Spain
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Primary sponsor type
Individual
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Name
Aitor Bano Alcaraz
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Address
Paseo Florencia, 23 3-A 30012 MURCIA
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Country
Spain
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Secondary sponsor category [1]
269105
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None
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Name [1]
269105
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Address [1]
269105
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Country [1]
269105
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Other collaborator category [1]
252315
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Individual
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Name [1]
252315
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Angel Oliva Pascual-Vaca
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Address [1]
252315
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C/ Goleta 6
41740 Lebrija (Sevilla)
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Country [1]
252315
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Spain
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Other collaborator category [2]
252327
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Individual
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Name [2]
252327
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Cleofas Rodriguez Blanco
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Address [2]
252327
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C/ Otono 35
41710 Utrera (Sevilla)
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Country [2]
252327
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Spain
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
272053
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Comite Etico de Experimentacion de la Universidad de sevilla
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Ethics committee address [1]
272053
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Comite de Etica. Pabellon de Brasil. Universidad de Sevilla. Paseo de las Delicias s/n 41013 SEVILLA
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Ethics committee country [1]
272053
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Spain
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Date submitted for ethics approval [1]
272053
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15/10/2011
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Approval date [1]
272053
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27/10/2011
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Ethics approval number [1]
272053
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Summary
Brief summary
we make a thoracic spinal manipulation trying to stimulate the orthosympathetic innervation and evaluating the influence about respiratory function inmediatly after the technique.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33311
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Address
33311
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Country
33311
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Phone
33311
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Fax
33311
0
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Email
33311
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Contact person for public queries
Name
16558
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Aitor Bano Alcaraz
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Address
16558
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PASEO FLORENCIA, 23 3-A 30012 MURCIA
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Country
16558
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Spain
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Phone
16558
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+34686539121
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Fax
16558
0
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Email
16558
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[email protected]
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Contact person for scientific queries
Name
7486
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Aitor Bano Alcaraz
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Address
7486
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PASEO FLORENCIA, 23 3-A 30012 MURCIA
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Country
7486
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Spain
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Phone
7486
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+34686539121
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Fax
7486
0
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Email
7486
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[email protected]
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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.
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