Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000509460
Ethics application status
Approved
Date submitted
27/09/2007
Date registered
5/10/2007
Date last updated
5/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reflex effects of a spinal adjustment on autonomic nervous system function
Scientific title
Autonomic nervous system changes in chiropractic patients following chiropractic adjustement or sham adjustment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
No problem will be studied. We are going to investigate reflex autonomic nervous system changes in 'normal' individuals. 2406 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2512 2512 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 2513 2513 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single chiropractic adjustment to the spine. The data collection session will last approximately 20 minutes.
Intervention code [1] 2129 0
Other interventions
Comparator / control treatment
Set up for chiropractic adjustment with no thrust
Control group
Placebo

Outcomes
Primary outcome [1] 3407 0
Short term change to autonomic nervous system function
Timepoint [1] 3407 0
Within 5 minutes post adjustment
Secondary outcome [1] 5665 0
None
Timepoint [1] 5665 0
NA

Eligibility
Key inclusion criteria
To be eligible to participate in this study volunteers must be an active patient at the New Zealand College of Chiropractic student health centre. Active is defined as receiving care at the student health centre within the previous six weeks. Volunteers must have no known contraindication to receiving a chiropractic adjustment and have experienced no previous significant adverse reactions to spinal adjustments
Minimum age
N/A
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers will not be eligible to participate in this study if they are currently taking blood pressure medication or if their blood pressure is classified as moderate or higher hypertension (systolic 160mmHg or greater or diastolic 100mmHg or greater) on the day they are to participate in the study. They will also be ineligible to participate if their blood pressure is less than 90/60mmHg on the day they are to participate in the study.

Volunteers will be asked not to take or consume any substance that is likely to have a significant effect on blood pressure on the day they will be involved in the study. This will include caffeine, tobacco, tea, coffee, cola, drugs or alcohol. They will also be asked not to partake in any significant physical exercise for at least 2 hours prior to their participation in the study.

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)
Participants will be approached during routine visits at the NZCC student health centre. Group allocation will be made centrally using a computerised random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Rando number generator will assign each participant to a group. Group allocation will not be revealed to investigators prior to data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 610 0
New Zealand
State/province [1] 610 0

Funding & Sponsors
Funding source category [1] 2658 0
Self funded/Unfunded
Name [1] 2658 0
New Zealand College of Chiropractic
Country [1] 2658 0
New Zealand
Primary sponsor type
Other
Name
New Zealand Coillege of Chiropractic
Address
15 Margot Street
Newmarket
Auckland
Country
New Zealand
Secondary sponsor category [1] 2404 0
None
Name [1] 2404 0
Address [1] 2404 0
Country [1] 2404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4578 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 4578 0
Ministry of Health
3rd Floor
BNZ Building
354 Victoria Street
Hamilton
Ethics committee country [1] 4578 0
New Zealand
Date submitted for ethics approval [1] 4578 0
02/07/2007
Approval date [1] 4578 0
13/09/2007
Ethics approval number [1] 4578 0
NTY/07/07/083

Summary
Brief summary
The purpose of this study is to investigate the effect a spinal adjustment on the autonomic nervous system (ANS). A spinal adjustment is the term chiropractors use for spinal manipulation. This study will investigate whether a single spinal adjustment results in short term changes to the ANS. Measures of ANS activity will include blood pressure, heart rate variability and other non-invasive modalities associated with autonomic function. This study will be conducted as a randomised controlled trial. Each trial will take place during a routine chiropractic visit at the New Zealand College of Chiropractic (NZCC) student health centre.The first trial we aim to conduct will involve monitoring blood pressure. During each trial participants will have their blood pressure taken and then have their spine checked by an experienced chiropractor. If assigned to the experimental group they will receive a spinal adjustment based on their palpation findings, the control group will be set up for an adjustment but no manipulation will take place. The groups will then have their blood pressure monitored immediately post intervention. Following this the participant will receive any further spinal adjustments deemed necessary based on their chiropractic analysis. Volunteers will be sought from active patients currently presenting to the NZCC student health centre.
Research Question: Does a spinal adjustment result in a short-term change in autonomic nervous system (ANS) activity? If so, does the nature of this change depend on the region of the spine adjusted?

Null hypothesis: That a spinal adjustment will cause no short-term change in ANS activity.
Hypothesis 1: That a spinal adjustment will cause a short term change in ANS activity.
Hypothesis 2: That the nature of the change in ANS activity following a spinal adjustment will be dependent on the region of the adjusted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28077 0
Address 28077 0
Country 28077 0
Phone 28077 0
Fax 28077 0
Email 28077 0
Contact person for public queries
Name 11234 0
Kelly Holt
Address 11234 0
NZCC
15 Margot Street
Newmarket
Auckland
Country 11234 0
New Zealand
Phone 11234 0
+64 9 522 5530
Fax 11234 0
Email 11234 0
[email protected]
Contact person for scientific queries
Name 2162 0
Kelly Holt
Address 2162 0
NZCC
15 Margot Street
Newmarket
Auckland
Country 2162 0
New Zealand
Phone 2162 0
+ 64 9 522 5530
Fax 2162 0
Email 2162 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.