Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001141831
Ethics application status
Approved
Date submitted
8/10/2012
Date registered
29/10/2012
Date last updated
14/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The short term effect of thorax manipulation on lung function
Scientific title
Among healthy participants, does thorax manipulation change pulmonary function?
Secondary ID [1] 281358 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary function 287580 0
Condition category
Condition code
Respiratory 287907 287907 0 0
Normal development and function of the respiratory system
Physical Medicine / Rehabilitation 288046 288046 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual therapy, including high-velocity, low amplitude manipulation and low velocity mobilization applied to the thoracic spine and costovertebral joints.

The manual therapy will take place during one ten minute treatment session.
Intervention code [1] 285820 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288123 0
Forced expiratory volume in one second. This will be assessed using a spirometer to measure the volume of air forcibly exhaled in one second.
Timepoint [1] 288123 0
baseline and repeated at 1 minute, 10 minutes, 20 minutes and 30 minutes following the manual therapy
Primary outcome [2] 288124 0
Maximal voluntary ventilation. This will be assessed using a spirometer to measure the volume of air exhaled during repetitive maximal inhalation and exhalation over 15 seconds.
Timepoint [2] 288124 0
baseline and repeated at 1 minute, 10 minutes, 20 minutes and 30 minutes following the manual therapy
Secondary outcome [1] 299458 0
Forced vital capacity. This will be assessed using a spirometer to measure the volume of air that can forcibly exhaled after a maximum inhalation.
Timepoint [1] 299458 0
baseline and repeated at 1 minute, 10 minutes, 20 minutes and 30 minutes following the manual therapy

Eligibility
Key inclusion criteria
Healthy
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of pulmonary disease (e.g., asthma, emphysema), smoking within the past 12 months, manual therapy in the previous 7 days, use of medications that affect pulmonary function, current pregnancy, or contraindications to manual therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be recruited from advertisement at the the Murdoch University campus.

Individuals interested in study participation will contact one of co-investigators and be scheduled for an appointment. At that time, the potential participants will complete a screening questionnaire to identify their status on all selection criteria. Eligible individuals will be provided with a research ethics information letter and consent form and be provided with the opportunity to have any questions or concerns addressed by a study co-investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study will use a pretest-posttest within subjects design involving repeated measures in the post-intervention period. Measures of pulmonary function will be obtained at baseline and repeated at 1 minute, 10 minutes, 20 minutes and 30 minutes following the manual therapy intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/11/2012
Actual
7/11/2012
Date of last participant enrolment
Anticipated
Actual
7/12/2012
Date of last data collection
Anticipated
Actual
7/12/2012
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286115 0
University
Name [1] 286115 0
Murdoch University
Country [1] 286115 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St.
Murdoch, Western Australia 6160
Country
Australia
Secondary sponsor category [1] 284927 0
None
Name [1] 284927 0
Address [1] 284927 0
Country [1] 284927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288163 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 288163 0
Ethics committee country [1] 288163 0
Australia
Date submitted for ethics approval [1] 288163 0
14/09/2012
Approval date [1] 288163 0
09/10/2012
Ethics approval number [1] 288163 0
2012/174

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

Contacts
Principal investigator
Name 34799 0
Dr Jeffrey Hebert
Address 34799 0
Murdoch University
90 South St.
Murdoch, Western Australia
Australia
Country 34799 0
Australia
Phone 34799 0
+61893602566
Fax 34799 0
Email 34799 0
[email protected]
Contact person for public queries
Name 18046 0
Jeffrey Hebert
Address 18046 0
Murdoch University
90 South St.
ECL 4.008
Murdoch, Western Australia
6160
Country 18046 0
Australia
Phone 18046 0
+61 8 9360 2566
Fax 18046 0
Email 18046 0
[email protected]
Contact person for scientific queries
Name 8974 0
Jeffrey Hebert
Address 8974 0
Murdoch University
90 South St.
ECL 4.008
Murdoch, Western Australia
6160
Country 8974 0
Australia
Phone 8974 0
+61 8 9360 2566
Fax 8974 0
Email 8974 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
Dimensions AIThe effect of manual therapy on pulmonary function in healthy adults2016https://doi.org/10.1038/srep33244
N.B. These documents automatically identified may not have been verified by the study sponsor.