Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000407897
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
14/04/2021
Date last updated
25/05/2022
Date data sharing statement initially provided
14/04/2021
Date results provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic Intervention and Oculomotor Function in Young Adults with Persistent Mild Traumatic Brain Injury Symptoms
Scientific title
Chiropractic Intervention and Oculomotor Function in Young Adults with Persistent Mild Traumatic Brain Injury Symptoms
Secondary ID [1] 303479 0
Nil known
Universal Trial Number (UTN)
U1111-1233-0051
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 320792 0
Spinal Function 320793 0
Condition category
Condition code
Injuries and Accidents 318612 318612 0 0
Other injuries and accidents
Neurological 318613 318613 0 0
Other neurological disorders
Musculoskeletal 318614 318614 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will first be assessed for inclusion criteria, if appropriate for this study they will undergo a baseline assessment, then be randomly allocated to either the intervention or control group and the appropriate intervention applied. The chiropractic intervention consists of a single session of chiropractic care. The control intervention will consist of a series of movements, detailed below, designed to account for vestibular and proprioceptive input that may occur in the course of a chiropractic session.

Chiropractic intervention will be provided by a volunteer chiropractor from Auckland. The attending chiropractor will be recruited or volunteer to provide care. Chiropractors will be asked to treat study participants like any other patient presenting to their practice.

Chiropractors will not be limited to any particular type or technique of care, so chiropractors will be able to tailor the care they provided to the participant’s individual clinical needs. This will enable chiropractors to modify the type and frequency of care throughout the trial, which reflects normal chiropractic clinical practice. This means that the nature of chiropractic care provided may vary between participants within the intervention group. Following the participant’s final assessment, their treating chiropractor will be asked for a description and frequency of care so a summary of interventions used in the trial can be presented.

Chiropractic care in this trial will involve the on-going provision of care, whether a subjective complaint is present or not, with the intention of correcting spinal dysfunction, which is termed vertebral subluxation by chiropractors (Haavik Taylor, Holt et al. 2010, Henderson 2012). Clinical indicators of vertebral subluxation, such as palpable restricted intersegmental range of motion and tenderness to palpation of the joint, can be used to guide the chiropractic clinical decision making process, as opposed to areas of pain or symptoms (Owens 2002, Cooperstein, Haneline et al. 2010, Henderson 2012). When applied in this fashion, the goal of chiropractic care is to enhance health as opposed to treating a specific subjective complaint (de Souza and Ebrall 2008). In this trial, all patients will be examined and treated using procedures that are customarily used in chiropractic practice, and that conform to best practice guidelines and the scope of chiropractic practice specified by the New Zealand Chiropractic Board (New Zealand Chiropractic Board 2007).

In general, chiropractic visits last from ten to thirty minutes and involve the chiropractor taking a subjective report, before assessing the participant, and providing chiropractic care based on the findings present and care plan recommendations. Chiropractors will be asked to inform the principal investigator if any serious adverse events occurred while the participant was under their care.

Chiropractic procedures that are commonly used predominantly consist of:
1. High velocity, low amplitude spinal and extremity adjustments with direct manual contact, typically resulting in joint cavitation (Evans 2002)
2. Table assisted chiropractic adjustments that involve direct manual contact of the spine and a segmental drop table to enhance the motion force imparted towards the segment or area to be adjusted (Homack 2005).
3. Very high velocity, low amplitude adjustments using a mechanical instrument for force delivery (Fuhr, Colloca et al. 1997, Nadler, Holder et al. 1998).

These procedures fall into a number of named proprietary technique packages that can be used on their own or in an eclectic approach. These named technique packages include Diversified Technique, Gonstead Chiropractic Technique, Activator Methods Chiropractic Technique, Thompson Technique, and Torque Release Technique (Cooperstein and Gleberzon 2004). Chiropractors will also be able to include rehabilitative exercises, stretching, and other non-adjustive treatments that are routinely used in chiropractic practice (Coulter and Shekelle 2005, Holt, Kelly et al. 2009).

The researchers choose to leave the decisions regarding the approach to care up to the individual chiropractors, as in the past, chiropractic researchers have been criticised for designing interventions in randomised controlled trials that do not reflect usual chiropractic practice (Hawk, Khorsan et al. 2007). It is thought that this prescriptive approach to trial interventions limits the generalisability of results from chiropractic trials when considered from a whole systems research point of view (Hawk, Khorsan et al. 2007, Rosner 2012).

The control intervention will include passive and active movements of the participants head, spine, and body. It will include moving the participant into spinal adjustment setup positions but without delivering an adjustment thrust or loading tension into any spinal joints. Pre-loading a joint, as is normal prior to spinal adjusting has been shown to alter paraspinal proprioceptive firing in anesthetised cats (Pickar & Wheeler, 2001). This intervention will control for possible physiological changes occurring due to the cutaneous, muscular, or vestibular input that would occur with the type of passive and active movements involved in assessing the participants prior to an adjustment and setting up for an adjustment. An active control involving passive and active movements has been chosen to determine if the difference in outcome measures is due to the application of a high-velocity low-amplitude thrust or other cutaneous, muscular, or vestibular input caused by passive and active movements during a chiropractic session.
Intervention code [1] 319767 0
Rehabilitation
Intervention code [2] 320035 0
Treatment: Other
Comparator / control treatment
The control intervention will include passive and active movements of the participants head, spine, and body. It will include moving the participant into spinal adjustment setup positions but without delivering an adjustment thrust or loading tension into any spinal joints. Pre-loading a joint, as is normal prior to spinal adjusting has been shown to alter paraspinal proprioceptive firing in anesthetised cats (Pickar & Wheeler, 2001). This intervention will control for possible physiological changes occurring due to the cutaneous, muscular, or vestibular input that would occur with the type of passive and active movements involved in assessing the participants prior to an adjustment and setting up for an adjustment. An active control involving passive and active movements has been chosen to determine if the difference in outcome measures is due to the application of a high-velocity low-amplitude thrust or other cutaneous, muscular, or vestibular input caused by passive and active movements during a chiropractic session.
Control group
Active

Outcomes
Primary outcome [1] 326572 0
Composite primary outcome - Oculomotor function: saccades, anti-saccades, fixations, smooth pursuits, pupillary dynamics, vestibulo-ocular reflex, multisensory integration and egocentric localisation using the Tobii eye tracker - a computerised measure of eye movements. All oculomotor function outcomes are recorded by the Tobii eye tracker in XML document format.
Timepoint [1] 326572 0
Primary outcomes will be assessed pre and post-intervention or control in a single session.
Secondary outcome [1] 392967 0
Nil
Timepoint [1] 392967 0
Nil

Eligibility
Key inclusion criteria
40 Young adults with persistent symptoms of mild traumatic brain injury (mTBI) and normal or corrected to normal vision
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any conditions that are known to affect eye-movements, such as Attention Deficit Hyperactivity Disorder (ADHD), stroke or cranial nerve palsy or vision loss in one or both eyes that is not corrected to normal via glasses or contact lenses.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on a previous study relating to chiropractic intervention on eye-tracking (Cade, Jones, Holt, Haavik, Heidi, 2016). Sample size calculations showed the need for a minimum number of 20 subjects per group (ß = 0.95, a = 0.05, effect size of 0.6). GPower version 3.0.10 (University of Kiel, Germany). To allow for relative uncertainty about the expected effect sizes, we aim to enrol a maximum of 40 participants in this trial.
Descriptive statistics such as unadjusted means, standard deviations, and counts will be used to describe the baseline characteristics of the two groups. Mixed models for repeated measures method will be used to analyse the effect of vibration on the change scores recorded pre and post-intervention for the primary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
23/06/2021
Date of last participant enrolment
Anticipated
1/09/2021
Actual
18/03/2022
Date of last data collection
Anticipated
1/12/2021
Actual
26/03/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 23469 0
New Zealand
State/province [1] 23469 0
Auckland

Funding & Sponsors
Funding source category [1] 307896 0
University
Name [1] 307896 0
The University of Auckland
Country [1] 307896 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Country
New Zealand
Secondary sponsor category [1] 308608 0
Individual
Name [1] 308608 0
Dr Kelly Jones
Country [1] 308608 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307894 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 307894 0
Ethics committee country [1] 307894 0
New Zealand
Date submitted for ethics approval [1] 307894 0
21/05/2019
Approval date [1] 307894 0
21/08/2019
Ethics approval number [1] 307894 0
2021 AM 8731

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 108850 0
Dr Phil Turnbull
Address 108850 0
The University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 108850 0
New Zealand
Phone 108850 0
+64 9 373 7599
Fax 108850 0
Email 108850 0
p.turnbull@auckland.ac.nz
Contact person for public queries
Name 108851 0
Alice Cade
Address 108851 0
The University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 108851 0
New Zealand
Phone 108851 0
+64 21 400739
Fax 108851 0
Email 108851 0
a.cade@auckland.ac.nz
Contact person for scientific queries
Name 108852 0
Alice Cade
Address 108852 0
The University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 108852 0
New Zealand
Phone 108852 0
+64 21 400739
Fax 108852 0
Email 108852 0
a.cade@auckland.ac.nz

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Public


Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data of primary and secondary outcomes only


What types of analyses could be done with individual participant data?
• Reproducing similar studies


When can requests for individual participant data be made (start and end dates)?
From:
Start date: 10/01/2022
End date: 10/01/2028

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• emailing the principal investigator: a.cade@auckland.ac.nz


Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.