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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
Scientific title
Will T4 Dog technique produce changes in spirometry values in smokers
Secondary ID [1] 273273 0
Nil
Universal Trial Number (UTN)
U1111-1125-4381
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smokers 279036 0
Respiratory function 279058 0
Condition category
Condition code
Respiratory 279223 279223 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 279224 279224 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269616 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 279854 0
changes in spirometric values (FVC, FEV1, PEF, FEF25-75%)
Timepoint [1] 279854 0
inmediatly after the technique
Secondary outcome [1] 294586 0
change in spirometric values from men against women
Timepoint [1] 294586 0
inmediatly after the technique
Secondary outcome [2] 294587 0
change in spirometric values by age
Timepoint [2] 294587 0
inmediatly after the technique
Secondary outcome [3] 294588 0
changes in spirometric values according to number of cigarettes smoked per day
Timepoint [3] 294588 0
inmediatly after the technique

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

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
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3930 0
Spain
State/province [1] 3930 0
Murcia

Funding & Sponsors
Funding source category [1] 284105 0
Self funded/Unfunded
Name [1] 284105 0
Aitor Bano Alcaraz
Country [1] 284105 0
Spain
Primary sponsor type
Individual
Name
Aitor Bano Alcaraz
Address
Paseo Florencia, 23 3-A 30012 MURCIA
Country
Spain
Secondary sponsor category [1] 269105 0
None
Name [1] 269105 0
Address [1] 269105 0
Country [1] 269105 0
Other collaborator category [1] 252315 0
Individual
Name [1] 252315 0
Angel Oliva Pascual-Vaca
Address [1] 252315 0
C/ Goleta 6
41740 Lebrija (Sevilla)
Country [1] 252315 0
Spain
Other collaborator category [2] 252327 0
Individual
Name [2] 252327 0
Cleofas Rodriguez Blanco
Address [2] 252327 0
C/ Otono 35
41710 Utrera (Sevilla)
Country [2] 252327 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272053 0
Comite Etico de Experimentacion de la Universidad de sevilla
Ethics committee address [1] 272053 0
Ethics committee country [1] 272053 0
Spain
Date submitted for ethics approval [1] 272053 0
15/10/2011
Approval date [1] 272053 0
27/10/2011
Ethics approval number [1] 272053 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33311 0
Address 33311 0
Country 33311 0
Phone 33311 0
Fax 33311 0
Email 33311 0
Contact person for public queries
Name 16558 0
Aitor Bano Alcaraz
Address 16558 0
PASEO FLORENCIA, 23 3-A 30012 MURCIA
Country 16558 0
Spain
Phone 16558 0
+34686539121
Fax 16558 0
Email 16558 0
osteopatiarondasur@hotmail.com
Contact person for scientific queries
Name 7486 0
Aitor Bano Alcaraz
Address 7486 0
PASEO FLORENCIA, 23 3-A 30012 MURCIA
Country 7486 0
Spain
Phone 7486 0
+34686539121
Fax 7486 0
Email 7486 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.