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Trial registered on ANZCTR


Registration number
ACTRN12607000020482
Ethics application status
Not yet submitted
Date submitted
8/01/2007
Date registered
10/01/2007
Date last updated
10/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reflex effects of a spinal adjustment on blood pressure
Scientific title
Reflex changes in patient's blood pressure following chiropractic adjustment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood pressure in chiropractic patients 1521 0
Condition category
Condition code
Blood 1619 1619 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - Chiropractic patients will be checked for spinal dysfunction and adjusted if necessary by a chiropractor at a single level. Blood pressure is measured pre and immediately post adjustment.
Intervention code [1] 1538 0
Treatment: Other
Comparator / control treatment
Control - Chiropractic patients are checked for spinal dysfunction and set up for a chiropractic adjustment but no thrust is deliviered. Blood pressure is measured pre and post set-up. The overall time required for each trial is roughly 15 minutes with the intervention taking roughly 1 minute to complete. Blood pressure readings will be taken roughly 5 minutes apart.
Control group
Placebo

Outcomes
Primary outcome [1] 2232 0
Change in blood pressure
Timepoint [1] 2232 0
Measured immediately pre and immediately post chiropractic adjustment
Secondary outcome [1] 3896 0
Nil
Timepoint [1] 3896 0

Eligibility
Key inclusion criteria
Chiropractic patients presenting to a field practice.
Minimum age
15 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindication to chiropractic adjustment.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects will be blinded in this trial
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 460 0
New Zealand
State/province [1] 460 0

Funding & Sponsors
Funding source category [1] 1766 0
Self funded/Unfunded
Name [1] 1766 0
Funding provided by investigators
Address [1] 1766 0
Country [1] 1766 0
Primary sponsor type
Individual
Name
Kelly Holt
Address
Country
Secondary sponsor category [1] 1570 0
Individual
Name [1] 1570 0
Randy Beck
Address [1] 1570 0
Country [1] 1570 0
Secondary sponsor category [2] 1571 0
Individual
Name [2] 1571 0
Stephen Sexton
Address [2] 1571 0
Country [2] 1571 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3297 0
New Zealand College of Chiropractic
Ethics committee address [1] 3297 0
Ethics committee country [1] 3297 0
New Zealand
Date submitted for ethics approval [1] 3297 0
Approval date [1] 3297 0
Ethics approval number [1] 3297 0

Summary
Brief summary
We wish to investigate whether chiropractic adjustments of the spine will result in an immediate reflex change in blood pressure and if a reflex change does occur will the direction of the change relate to the area of the spine being adjusted
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27472 0
Address 27472 0
Country 27472 0
Phone 27472 0
Fax 27472 0
Email 27472 0
Contact person for public queries
Name 10727 0
Kelly Holt
Address 10727 0
New Zealand College of Chiropractic
15 Margot Street
Epsom 1051
Country 10727 0
New Zealand
Phone 10727 0
+64 9 5225530
Fax 10727 0
+64 9 5225539
Email 10727 0
spineworks@ihug.co.nz
Contact person for scientific queries
Name 1655 0
Kelly Holt
Address 1655 0
New Zealand College of Chiropractic
15 Margot Street
Epsom 1051
Country 1655 0
New Zealand
Phone 1655 0
+64 9 5225530
Fax 1655 0
+64 9 5225539
Email 1655 0
spineworks@ihug.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary