ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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.

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Alternative and Complementary Medicine

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]

Other interventions

Comparator / control treatment

Set up for chiropractic adjustment with no thrust

Control group

Placebo

Outcomes

Primary outcome [1]

Short term change to autonomic nervous system function

Timepoint [1]

Within 5 minutes post adjustment

Secondary outcome [1]

None

Timepoint [1]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

New Zealand College of Chiropractic

Address [1]

15 Margot Street
Newmarket
Auckland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
3rd Floor
BNZ Building
354 Victoria Street
Hamilton

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

02/07/2007

Approval date [1]

13/09/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Kelly Holt

Address

NZCC
15 Margot Street
Newmarket
Auckland

Country

New Zealand

Phone

+64 9 522 5530

Fax

spineworks@ihug.co.nz

Contact person for scientific queries

Name

Kelly Holt

Address

NZCC
15 Margot Street
Newmarket
Auckland

Country

New Zealand

Phone

+ 64 9 522 5530

Fax

spineworks@ihug.co.nz

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.

Trial Review

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