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Trial registered on ANZCTR


Registration number
ACTRN12607000270415
Ethics application status
Approved
Date submitted
13/03/2007
Date registered
18/05/2007
Date last updated
18/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hormone and immune function changes following Chiropractic Spinal Manipulative Therapy for Chronic Asthma sufferers.
Scientific title
A randomised controlled trial to assess the impact of chiropractic spinal manipulative therapy for co-managing chronic asthma sufferers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Asthma 1810 0
Condition category
Condition code
Respiratory 1900 1900 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic Asthma Sufferers who qualified for this study were randomly allocated to three groups, A, B and C. Groups A attended treatment centers and only group A receive 3 spinal manipulative therapy sessions per week for up to 6-weeks, in one of 19 treating centers within NSW. Randomly allocated control participants in group B also attended treating centers and participated in all assessments criteria but did not receive any spinal manipulative therapy for 6-weeks. Assessment included interviews with attending clinician, palpation of the spine (hands on assessment of spinal motion only), completed questionnaires and submitted salivary samples. However, Group C participants provided all salivary samples and questionnaire for the same period of 6-weeks from home.

Spinal manipulative therapy involves the use of hands on techniques to articulate vertebral joints. Specifically this chiropractic technique involved a high velocity low amplitude thrust delivered in a desired direction to restore joint motion. On average a treatment session would be between 15 and 20 minutes.
Intervention code [1] 1647 0
Treatment: Other
Comparator / control treatment
Effectively, Group B is the control group for Group A while Group C acts as another control for group B.
Control group
Active

Outcomes
Primary outcome [1] 2705 0
Changes in baseline cortisol and Immunoglobulin A (IgA) levels were analysed from salivary samples
Timepoint [1] 2705 0
Salivary samples collected on Tuesdays, Thursdays and Sundays at 8AM and 8PM. Salivary samples were collected for 14 weeks from each participant.
Secondary outcome [1] 4564 0
All participants completed a Depression Anxiety Stress Scale (DASS), a wellness questionnaire (SF-36) and an Asthma global questionnaire.
Timepoint [1] 4564 0
These were administered at the beginning of the trial (day1 week 1), at day 1 week 7 and at day 7 week 14.

Eligibility
Key inclusion criteria
Chronic asthma sufferers with a minimum of 6-months diagnosis and who were on a regularly managed medical program were included into this study.
Minimum age
9 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who fulfilled the inclusion criteria and who have received spinal manipulative therapy during the last 6-months period were excluded from the study. Equally, subject who had other associated health complications such as osteopenia or osteoporosis due to long term corticosteroid therapy were excluded.

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 was concealed from all decisions as to what group a participant is likely to be in by independently using a central computer based randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer based random number generator was used to allocate participants into the three Asthma groups. Participants were allocated into three parallel groups (groups A, B and C). Group A received the treatment while groups B and C acted as controls.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects were instructed that their treatment program will consist of 14 weeks of participation and at various times throughout the fourteen weeks they will receive a variety of manipulative interventions. They were not aware of when they will receive the SMT. Effectively both groups A and B believed that they will receive SMT, however, group A was the only group that did. As such participants were masked. However, the clinicians who delivered the therapy itself were not blinded simply due to the nature of this type hands on of manual therapy, effectively a single blind study design.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2046 0
Charities/Societies/Foundations
Name [1] 2046 0
Foundation for Chiropractic Education and Reserach USA
Country [1] 2046 0
United States of America
Primary sponsor type
University
Name
Macquarie University
Address
Sydney NSW 2109
Country
Australia
Secondary sponsor category [1] 1852 0
University
Name [1] 1852 0
Department of Health and Chiropractic, Division of Environmental and Life Sciences, Macquarie University 2109
Address [1] 1852 0
Country [1] 1852 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3782 0
Artarmon
Ethics committee address [1] 3782 0
Ethics committee country [1] 3782 0
Australia
Date submitted for ethics approval [1] 3782 0
Approval date [1] 3782 0
Ethics approval number [1] 3782 0
26 May 2000-R042
Ethics committee name [2] 3783 0
Bondi Junction
Ethics committee address [2] 3783 0
Ethics committee country [2] 3783 0
Australia
Date submitted for ethics approval [2] 3783 0
Approval date [2] 3783 0
Ethics approval number [2] 3783 0
26 May 2000-R042
Ethics committee name [3] 3784 0
Camden
Ethics committee address [3] 3784 0
Ethics committee country [3] 3784 0
Australia
Date submitted for ethics approval [3] 3784 0
Approval date [3] 3784 0
Ethics approval number [3] 3784 0
26 May 2000-R042
Ethics committee name [4] 3785 0
Concord
Ethics committee address [4] 3785 0
Ethics committee country [4] 3785 0
Australia
Date submitted for ethics approval [4] 3785 0
Approval date [4] 3785 0
Ethics approval number [4] 3785 0
26 May 2000-R042
Ethics committee name [5] 3786 0
Dee Why
Ethics committee address [5] 3786 0
Ethics committee country [5] 3786 0
Australia
Date submitted for ethics approval [5] 3786 0
Approval date [5] 3786 0
Ethics approval number [5] 3786 0
26 May 2000-R042
Ethics committee name [6] 3787 0
Curl Curl
Ethics committee address [6] 3787 0
Ethics committee country [6] 3787 0
Australia
Date submitted for ethics approval [6] 3787 0
Approval date [6] 3787 0
Ethics approval number [6] 3787 0
26 May 2000-R042
Ethics committee name [7] 3788 0
Drummoyne
Ethics committee address [7] 3788 0
Ethics committee country [7] 3788 0
Australia
Date submitted for ethics approval [7] 3788 0
Approval date [7] 3788 0
Ethics approval number [7] 3788 0
26 May 2000-R042
Ethics committee name [8] 3789 0
Eastlakes
Ethics committee address [8] 3789 0
Ethics committee country [8] 3789 0
Australia
Date submitted for ethics approval [8] 3789 0
Approval date [8] 3789 0
Ethics approval number [8] 3789 0
26 May 2000-R042
Ethics committee name [9] 3790 0
Fairlight
Ethics committee address [9] 3790 0
Ethics committee country [9] 3790 0
Australia
Date submitted for ethics approval [9] 3790 0
Approval date [9] 3790 0
Ethics approval number [9] 3790 0
26 May 2000-R042
Ethics committee name [10] 3791 0
Lane Cove
Ethics committee address [10] 3791 0
Ethics committee country [10] 3791 0
Australia
Date submitted for ethics approval [10] 3791 0
Approval date [10] 3791 0
Ethics approval number [10] 3791 0
26 May 2000-R042
Ethics committee name [11] 3792 0
Liverpool
Ethics committee address [11] 3792 0
Ethics committee country [11] 3792 0
Australia
Date submitted for ethics approval [11] 3792 0
Approval date [11] 3792 0
Ethics approval number [11] 3792 0
26 May 2000-R042
Ethics committee name [12] 3793 0
Mosman
Ethics committee address [12] 3793 0
Ethics committee country [12] 3793 0
Australia
Date submitted for ethics approval [12] 3793 0
Approval date [12] 3793 0
Ethics approval number [12] 3793 0
26 May 2000-R042
Ethics committee name [13] 3794 0
Wentworthville
Ethics committee address [13] 3794 0
Ethics committee country [13] 3794 0
Australia
Date submitted for ethics approval [13] 3794 0
Approval date [13] 3794 0
Ethics approval number [13] 3794 0
26 May 2000-R042
Ethics committee name [14] 3795 0
Westleigh
Ethics committee address [14] 3795 0
Ethics committee country [14] 3795 0
Australia
Date submitted for ethics approval [14] 3795 0
Approval date [14] 3795 0
Ethics approval number [14] 3795 0
26 May 2000-R042
Ethics committee name [15] 3796 0
Sydney
Ethics committee address [15] 3796 0
Ethics committee country [15] 3796 0
Australia
Date submitted for ethics approval [15] 3796 0
Approval date [15] 3796 0
Ethics approval number [15] 3796 0
26 May 2000-R042
Ethics committee name [16] 3797 0
Hornsby
Ethics committee address [16] 3797 0
Ethics committee country [16] 3797 0
Australia
Date submitted for ethics approval [16] 3797 0
Approval date [16] 3797 0
Ethics approval number [16] 3797 0
26 May 2000-R042
Ethics committee name [17] 3799 0
Miranda
Ethics committee address [17] 3799 0
Ethics committee country [17] 3799 0
Australia
Date submitted for ethics approval [17] 3799 0
Approval date [17] 3799 0
Ethics approval number [17] 3799 0
26 May 2000-R042

Summary
Brief summary
This clinical trial was developed to look at the role that chiropractic may have in co-managing asthma sufferers with spinal manipulative therapy (SMT). A multisite clinical trial was conducted that attracted up to 160 participants. Randomly allocated participants were assigned to one of three groups (A, B and C) for a period of 14-weeks of participation. Participants in group A received up to 18 chiropractic SMT sessions. During this time all participants in all groups provided regular salivary samples for hormone (cortisol) and immune (immunoglobulin A) function analysis as well as wellness questionnaires. Groups B and C did not receive any spinal manipulative therapy.

The aims of this study were to determine whether stress is a factor in the pathophysiology of asthma and to determine the mechanisms by which chiropractic co-management of asthma sufferers can alleviate their symptoms. More specifically, our study aimed at determining whether chiropractic treatment has beneficial effects on the endocrine and the immune systems through measurement of salivary cortisol and salivary immunoglobulin A (IgA) respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27581 0
Address 27581 0
Country 27581 0
Phone 27581 0
Fax 27581 0
Email 27581 0
Contact person for public queries
Name 10836 0
Dr Ray Hayek
Address 10836 0
Suite 222
E7A
Macquarie University
Sydney NSW 2109
Country 10836 0
Australia
Phone 10836 0
+61 2 98506382
Fax 10836 0
Email 10836 0
[email protected]
Contact person for scientific queries
Name 1764 0
Dr Ray Hayek
Address 1764 0
Suite 222
E7A
Macquarie University
Sydney NSW 2109
Country 1764 0
Australia
Phone 1764 0
+61 2 98506382
Fax 1764 0
Email 1764 0
[email protected]

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