ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001035819

Ethics application status

Approved

Date submitted

15/07/2021

Date registered

5/08/2021

Date last updated

20/02/2023

Date data sharing statement initially provided

5/08/2021

Date results provided

14/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Human body’s response to neck treatment

Scientific title

Autonomic nervous system and endocrine system response to upper and lower cervical spine mobilization in healthy male adults: a randomized crossover trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1268-0679

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Persistent post-concussion symptoms

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Cervical spine mobilization manual therapy technique
-Arm 1-Upper cervical spine mobilization applied to C0-1 and C1-2 for 3 lots of 2 minutes each, separated by a 30 second rest.
-Arm 2-Lower cervical spine mobilization applied to C6-7 and C7-T1 for 3 lots of 2 minutes each, separated by a 30 second rest.
Each mobilization will be low frequency, mid-range, bilateral and alternating oscillations.
All interventions will be performed by the same operator (certified musculoskeletal physiotherapist specialist with over 30 years clinical experience), face to face, and on an individual basis.
The intervention will be delivered 2 times. One session will be upper cervical mobilisation, and the other will be lower cervical mobilisation, separated by a 1 week washout period. Each participant will receive each intervention. The order of intervention will be randomized.
Each intervention will be held in the same room at the School of Physiotherapy, University of Otago, Dunedin, New Zealand.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Active control. Patients act as their own control-we are performing a randomised controlled cross over trial. A comparison is being made between upper cervical mobilization (arm 1) and lower cervical mobilization (arm 2). There is no reference comparator as we are investigating the different response between each mobilization.

Control group

Active

Outcomes

Primary outcome [1]

Difference in salivary cortisol levels measured with the unstimulated passive drool salivary sample technique

Timepoint [1]

30 minutes post-intervention

Secondary outcome [1]

-Difference in salivary cortisol levels measured with the unstimulated passive drool salivary sample technique

Timepoint [1]

-Cortisol-5 minutes post-intervention, night (1000-2400) post-intervention

Secondary outcome [2]

-Difference in heart rate variability (rMSSD-specific index we are using for secondary analysis) measured with Camera HRV smart phone application

Timepoint [2]

-Heart rate variability (rMSSD)-5 minutes post-intervention, 30 minutes post-intervention, morning (0600-0800) post-intervention

Eligibility

Key inclusion criteria

Healthy males aged between 21-35 years old who own an iPhone and have no current pain, illness or injury.

Minimum age

21 Years

Maximum age

35 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants will be excluded if they have a history of a serious medical or psychiatric disorder, are currently on systemic glucocorticoid or cardioactive medication, or currently have an endocrine, central nervous system, cardiovascular or a mental health disorder. To ensure participants are safe to receive the intervention, they will be screened in more detail for any contra-indications to manual therapy (i.e. fracture, dislocation, spinal cord damage) and will be excluded accordingly. If any precautions to manual therapy are present (i.e. systemically unwell, osteoporosis, throat infection), participants will be excluded on a case by case basis.

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)

This trial includes allocation concealment. Participants will be block randomized by use of sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Our randomized controlled crossover trial will consist of two repeating blocks of two periods (AB BA). The order of treatment for Block-AB is upper cervical mobilization followed by lower cervical mobilization, and vise versa for Block-BA. Simple randomisation using coin-tossing will be used to determine the order of treatment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Power analysis-
We worked with biostatistician as an advisor for this project. No previous studies have investigated the effect of cervical mobilization on our primary outcome of interest, salivary cortisol. Therefore, we cannot power our study using expected differences of means and standard deviations. We anticipate a large effect size due to our mobilisation locations (upper or lower cervical spine) being anatomically separate from each other. Due to the opposite effects hypothesised, we anticipate a large effect size. Cohen has suggested that d=0.8 be considered a large effect size. A priori sample size calculation using G*Power estimated that a sample size of n=15 was required to provide 0.8 power at a=0.05 with an effect size of 0.8 using a two tailed test. A smaller sample size is required for a larger anticipated effect size, therefore we expect to find a large effect size from our sample of 15 (20 when taking into account loss to follow up).
Statistical analysis-
Due to the crossover nature of our trial and repeated measures within each individual, our outcomes are non-independent of each other. To explicitly account for correlations between repeated measures, and to answer the research question, we will use a mixed model approach as our statistic test. The mixed model will include fixed effects and random effects. Fixed effects will include the treatment group, timing of measurement and treatment group x time interaction. Random effects will include outcome (heart rate variability, salivary cortisol) response, timing of the intervention, and baseline recordings. The primary statistic of interest will be the interaction between treatment group and time.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

9/08/2021

Actual

13/09/2021

Date of last participant enrolment

Anticipated

23/08/2021

Actual

24/09/2021

Date of last data collection

Anticipated

8/10/2021

Actual

13/10/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Stanley Paris PhD OMT Scholarship, University of Otago

Address [1]

University of Otago
Research Division
PO Box 56, Dunedin 9054, New Zealand

Country [1]

New Zealand

Funding source category [2]

University

Name [2]

University of Otago Doctoral Scholarship

Address [2]

Shared Services Divisional Office
PO Box 56 Dunedin, 9054

Country [2]

New Zealand

Primary sponsor type

Individual

Name

Gerard Farrell

Address

School of Physiotherapy clinics, ground floor, 325 Great King Street, North Dunedin, Dunedin 9016

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Steve Tumilty

Address [1]

School of Physiotherapy reception, third floor, 325 Great King Street, North Dunedin, Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

Academic Committees Office
Academic Division
University of Otago
PO Box 56, Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

09/06/2021

Approval date [1]

01/07/2021

Ethics approval number [1]

H21/086

Summary

Brief summary

The human body's response to stress, illness or injury is the stress response. It has two components which work together. These are the autonomic nervous system and endocrine system. The stress response can either be increased or decreased. If it is increased you may feel alert and your heart may beat fast, whereas if it is decreased you may feel sleepy and your heart beats slowly. Smartphone application measurements and saliva samples will be used to measure the autonomic and endocrine system parts of the stress response before and after gentle movements of joints in participants necks. The primary goal of this research is to investigate whether therapeutic movement of the joints at top of the neck compared to moving the joints at the bottom of the neck cause a different ‘stress response’, as measured by changes in the autonomic and endocrine systems. Due to the anatomy of the neck, we hypothesise that moving the upper joints in the neck will decrease the stress response, whereas moving the joints at the bottom of the neck will increase the stress response.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Steve Tumilty

Address

Centre for Health, Activity, and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016

Country

New Zealand

Phone

+64 3 479 7193

Fax

steve.tumilty@otago.ac.nz

Contact person for public queries

Name

Gerard Farrell

Address

School of Physiotherapy Clinics
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016

Country

New Zealand

Phone

+64 3 479 7460

Fax

gerard.farrell@otago.ac.nz

Contact person for scientific queries

Name

Gerard Farrell

Address

School of Physiotherapy Clinics
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016

Country

New Zealand

Phone

+64 3 479 7460

Fax

gerard.farrell@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

After de-identification, individual participant data underlying the published results only.

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Any individual who has access to the full text publication will have access to the de-identified data.

Available for what types of analyses?

The data will be available only to achieve the aims of the approved proposal and to provide details regarding the participants (de-identified). Other authors who have access to the full text publication will be able to use the data for a meta-analysis if applicable.

How or where can data be obtained?

Raw data will be in the repository and made available on request (University of Otago 'OUR Archive' PhD repository, the link is https://ourarchive.otago.ac.nz/). Depending upon the journal that accepts this work for publication, the raw data may be made available as an appendix file.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12544	Study protocol				In the future, the protocol will be available in a... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Autonomic nervous system and endocrine system response to upper and lower cervical spine mobilization in healthy male adults: a randomized crossover trial.	2023	https://dx.doi.org/10.1080/10669817.2023.2177071

N.B. These documents automatically identified may not have been verified by the study sponsor.

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