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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
5/08/2021
Date data sharing statement initially provided
5/08/2021
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] 304780 0
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 322841 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320421 320421 0 0
Physiotherapy
Neurological 320616 320616 0 0
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] 321160 0
Treatment: Other
Intervention code [2] 321161 0
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] 328262 0
Difference in salivary cortisol levels measured with the unstimulated passive drool salivary sample technique
Timepoint [1] 328262 0
30 minutes post-intervention
Secondary outcome [1] 398269 0
-Difference in salivary cortisol levels measured with the unstimulated passive drool salivary sample technique
Timepoint [1] 398269 0
-Cortisol-5 minutes post-intervention, night (1000-2400) post-intervention
Secondary outcome [2] 398996 0
-Difference in heart rate variability (rMSSD-specific index we are using for secondary analysis) measured with Camera HRV smart phone application
Timepoint [2] 398996 0
-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
Gender
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
Not yet recruiting
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] 23969 0
New Zealand
State/province [1] 23969 0
Otago

Funding & Sponsors
Funding source category [1] 309153 0
University
Name [1] 309153 0
The Stanley Paris PhD OMT Scholarship, University of Otago
Address [1] 309153 0
University of Otago
Research Division
PO Box 56, Dunedin 9054, New Zealand
Country [1] 309153 0
New Zealand
Funding source category [2] 309154 0
University
Name [2] 309154 0
University of Otago Doctoral Scholarship
Address [2] 309154 0
Shared Services Divisional Office
PO Box 56 Dunedin, 9054
Country [2] 309154 0
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] 310108 0
Individual
Name [1] 310108 0
Steve Tumilty
Address [1] 310108 0
School of Physiotherapy reception, third floor, 325 Great King Street, North Dunedin, Dunedin 9016
Country [1] 310108 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309018 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 309018 0
Academic Committees Office
Academic Division
University of Otago
PO Box 56, Dunedin 9054
Ethics committee country [1] 309018 0
New Zealand
Date submitted for ethics approval [1] 309018 0
09/06/2021
Approval date [1] 309018 0
01/07/2021
Ethics approval number [1] 309018 0
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 112662 0
A/Prof Steve Tumilty
Address 112662 0
Centre for Health, Activity, and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016
Country 112662 0
New Zealand
Phone 112662 0
+64 3 479 7193
Fax 112662 0
Email 112662 0
steve.tumilty@otago.ac.nz
Contact person for public queries
Name 112663 0
Mr Gerard Farrell
Address 112663 0
School of Physiotherapy Clinics
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016
Country 112663 0
New Zealand
Phone 112663 0
+64 3 479 7460
Fax 112663 0
Email 112663 0
gerard.farrell@otago.ac.nz
Contact person for scientific queries
Name 112664 0
Mr Gerard Farrell
Address 112664 0
School of Physiotherapy Clinics
University of Otago
325 Great King Street
North Dunedin
Dunedin, 9016
Country 112664 0
New Zealand
Phone 112664 0
+64 3 479 7460
Fax 112664 0
Email 112664 0
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?
Study protocol
How or where can supporting documents be obtained?
Type [1] 12544 0
Study protocol
Citation [1] 12544 0
Link [1] 12544 0
Email [1] 12544 0
Other [1] 12544 0
In the future, the protocol will be available in a journal. The study protocol has not been published yet.
Attachment [1] 12544 0
Summary results
No Results