Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000449538
Ethics application status
Approved
Date submitted
17/10/2006
Date registered
18/10/2006
Date last updated
9/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of spinal manipulation on respiratory function - a pilot study
Scientific title
The effect of combining spinal manipulation with exercise on the respiratory function of normal individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Change in respiratory function of normal individuals 1422 0
Condition category
Condition code
Respiratory 1519 1519 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial measures the effect of administering spinal manipulation with and without exercise on the respiratory function of normal individuals. Participants with lung volume measurements at the lower end of the normal range are allocated to 4 experimental groups. Group 1 receives exercise only; Group 2 receives spinal manipulation only; Group 3 receives spinal manipulation & exercise; Group 4 receives no intervention (Control). Each participant receives 6 intervention sessions over a 4 week period.
Intervention code [1] 1406 0
Treatment: Other
Comparator / control treatment
Group 4 receives no intervention (Control)
Control group
Active

Outcomes
Primary outcome [1] 2096 0
Spirometry.
Timepoint [1] 2096 0
Pre & post intervention, sessional 1 - 6 sessions
Primary outcome [2] 2097 0
Forced Vital Capacity (FVC).
Timepoint [2] 2097 0
Pre & post intervention, sessional 1 - 6 sessions
Primary outcome [3] 2098 0
Forced Expiratory Volume in 1st second (FEV-1).
Timepoint [3] 2098 0
Pre & post intervention, sessional 1 - 6 sessions
Secondary outcome [1] 3629 0
None
Timepoint [1] 3629 0

Eligibility
Key inclusion criteria
Non-smoking (minimum 6 months).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of respiratory diseaseThe existance of contra-indications to spinal manipulationNon-ambulatory status.

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)
Allocation to intervention groups was concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation was done by simple randomisation using dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1654 0
University
Name [1] 1654 0
Macquarie University
Country [1] 1654 0
Australia
Primary sponsor type
Individual
Name
Roger Engel
Address
Country
Secondary sponsor category [1] 1462 0
Individual
Name [1] 1462 0
Subra Vemulpad
Address [1] 1462 0
Country [1] 1462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3102 0
Macquarie University Ethics Review Committee (Human Research)
Ethics committee address [1] 3102 0
Ethics committee country [1] 3102 0
Australia
Date submitted for ethics approval [1] 3102 0
Approval date [1] 3102 0
19/03/2002
Ethics approval number [1] 3102 0
HE30NOV2001-R01716

Summary
Brief summary
Respiratory function involves movement of structures related to the Cervical and Thoracic spines. Evidence exists that the application of spinal manipulation to these areas can alter respiratory function. This study tests the effect administering spinal manipulation with exercise has on the respiratory function of normal individuals. The aim is to develop a pulmonary rehabilitation protocol that includes spinal manipulation for use in the management of chronic respiratory disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27340 0
Address 27340 0
Country 27340 0
Phone 27340 0
Fax 27340 0
Email 27340 0
Contact person for public queries
Name 10595 0
Roger Engel
Address 10595 0
Department of Health & Chiropractic
Macquarie university
Sydney New South Wales 2109
Country 10595 0
Australia
Phone 10595 0
+61 2 9850 6387
Fax 10595 0
+61 2 9850 9389
Email 10595 0
[email protected]
Contact person for scientific queries
Name 1523 0
Roger Engel
Address 1523 0
Department of Health & Chiropractic
Macquarie university
Sydney NSW 2109
Country 1523 0
Australia
Phone 1523 0
+61 2 9850 6387
Fax 1523 0
+61 2 9850 9389
Email 1523 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.