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Trial registered on ANZCTR


Registration number
ACTRN12625000053426p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the neurophysiological effects of chiropractic care in infants: a feasibility study
Scientific title
Feasibility of recording resting-state EEG and ECG in infants receiving chiropractic care
Secondary ID [1] 313444 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal 335835 0
Neurological 335836 0
Condition category
Condition code
Neurological 332413 332413 0 0
Studies of the normal brain and nervous system
Musculoskeletal 332414 332414 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be placed in the intervention or control group using alternating allocation (eg. first participant will be in intervention, second in control, third in intervention etc.).

The intervention consists of a single 30-minute session of chiropractic care. Chiropractic adjustments (treatment) is given with the infant lying supine or prone (depending on segment and type of adjustment) on a special pillow with the centre hollowed out for comfort and safety. If the infant is distressed, then the adjustment can be given whilst the infant is held by the caregiver.
The intervention will consist of gentle chiropractic adjustments to dysfunctional spinal segments and cranial sutures. The intervention will be provided by a chiropractor with significant training and experience (10+ years) in paediatric chiropractic care. The intervention will be delivered in a pragmatic approach based on the assessment of the chiropractor, rather than a pre-prescribed treatment, as this reflects standard practice and ensures that the spine and cranial dysfunctions are addressed on an individual basis.
Spinal adjustments involve placing a light fingertip contact on the restricted side of the affected segment and applying gentle pressure, which is held for several seconds until the therapist feels a change in the muscle tone. Cranial adjustments are given by placing light fingertip contacts along the restricted cranial sutures and applying gentle pressure with small strokes into the area. All spinal and cranial adjustments provided will be documented by the chiropractor.

Immediately prior to the intervention EEG will be recorded using a 14-channel disposable cap (Greentek Flex-Cap). This elastic cap allows for comfortable, high-quality signal EEG recording with a one size fits most newborn sized cap.
EEG preparation will include placing the cap onto the infant’s head and securing the Velcro chin strap. Conductive gel will be injected into each electrode by a syringe with a blunt needle, and then each electrode will be gently pressed down to ensure the gel reaches the scalp. This is needed to reduce the impendence and ensure excellent quality EEG signals. The impedance of the electrodes will be kept below 10kOhms. The EEG preparation will take approximately 10 minutes.
Following the preparation, infants will be swaddled and placed in a supine position on a special pillow with the centre hollowed out for comfort and safety; the caregiver will be seated next to the infant to keep the infant calm. Infants will be in a quiet but awake state during recording .The EEG signals will be checked by an EEG specialist to ensure clear, artifact-free signal conduction. Once clear signals have been confirmed, resting-state EEG will be recorded from infants for 5 minutes. The EEG cap will then be removed and the intervention. The cap must be removed because it involves cranial adjustments that cannot be performed with the cap in place. Immediately following the intervention the EEG cap will be placed back on the infant, signals checked, and if clear another 5 minutes of recording will take place with the infant in a quiet, but awake state.

At the same time as the EEG recording, heart rate variability (HRV) will also be recorded via a three- lead ECG. ECG electrodes will be placed on the infants chest in the following positions: right arm (RA) electrode will be placed under the right clavicle at the second intercostal space at the mid-clavicular line; the left arm (LA) electrode will be placed under the left clavicle at the second intercostal space at the mid-clavicular line; the left leg (LL) electrode will be placed on the left side below the pectoral muscles on the lower rib cage. The ECG leads will then be connected to the electrodes and the amplifier for recording. Recording will take place immediately before and after the intervention or control.

Following the completion of the EEG and ECG recordings, the data will be saved and briefly checked by an EEG specialist to ensure adequate recording has taken place.
Intervention code [1] 330020 0
Treatment: Other
Comparator / control treatment
The control group infants will be placed on the special pillow with the centre hollowed out for comfort and safety. If the infant is distressed, then the infant is held by the caregiver. The chiropractor will hold, gently palpate and talk to the infant in a comparable manner to the intervention, but no adjustments will be performed. This will be conducted for the same time as the intervention session to control for the effects of time, attention and touch given to the infant.
Control group
Active

Outcomes
Primary outcome [1] 339993 0
Completeness of resting-state EEG data
Timepoint [1] 339993 0
Completion assessed immediately pre/post intervention or control.
EEG data assessed within one week of experimental session.
Primary outcome [2] 339994 0
Tolerability of the EEG preparation
Timepoint [2] 339994 0
Infant distress monitored every 5 minutes throughout the experimental session.
Success of EEG preparation assessed immediately at the completion of the preparation.
Adverse events data will collected for up to 24 hours post- experimental session.
Primary outcome [3] 339995 0
Tolerability of EEG recording
Timepoint [3] 339995 0
Immediately pre and post intervention/control
Secondary outcome [1] 442243 0
Changes in EEG band power following the chiropractic intervention compared to control
Timepoint [1] 442243 0
EEG analysis completed within one week post experimental session.
Secondary outcome [2] 442244 0
Completeness of heart rate variability (HRV) data from ECG recordings
Timepoint [2] 442244 0
Completeness assessed immediately pre and post intervention/control.
ECG recordings review completed within one week of experimental session.

Eligibility
Key inclusion criteria
Infants, born at term age with evidence of dysfunctional spinal segments and/or dysfunctional cranial sutures as determined by treating chiropractor. Evidence of dysfunctional spinal segments and/or cranial sutures will be based on the presence of all or some of the following criteria:
Spinal dysfunction is characterised by a restricted intersegmental range of movement, palpable asymmetric intervertebral muscle tension, unusual or blocked joint play and a restricted global range of movement.
Cranial dysfunction in infants is assessed through gentle motioning along the cranial suture lines and feeling for reduced movement or stiffness and/or asymmetrical shape of the skull, observation of the symmetry of the facial structures, and assessment of the tongue movement and function
Minimum age
4 Weeks
Maximum age
6 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with known congenital anomalies of the central nervous system, chromosomal abnormalities, complex congenital heart disease, non-intact skin on the scalp, any absolute contraindications to chiropractic adjustments (spinal fracture, spinal infection, spinal tumor), no evidence of spinal dysfunction or infants that have had a previous significant adverse response to chiropractic care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
24/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 26758 0
New Zealand
State/province [1] 26758 0

Funding & Sponsors
Funding source category [1] 317883 0
Commercial sector/Industry
Name [1] 317883 0
Australian Spinal Research Foundation
Country [1] 317883 0
Australia
Funding source category [2] 317913 0
Commercial sector/Industry
Name [2] 317913 0
The Kids Summit
Country [2] 317913 0
Australia
Primary sponsor type
Individual
Name
Jenna Salmons- New Zealand College of Chiropractic and The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320220 0
University
Name [1] 320220 0
University of Auckland
Address [1] 320220 0
Country [1] 320220 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316568 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316568 0
Ethics committee country [1] 316568 0
New Zealand
Date submitted for ethics approval [1] 316568 0
06/01/2025
Approval date [1] 316568 0
Ethics approval number [1] 316568 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138274 0
Dr Angus McMorland
Address 138274 0
Department of Exercise Sciences, University of Auckland, Newmarket, 1023, Private Bag 92019, Auckland
Country 138274 0
New Zealand
Phone 138274 0
+64 9 3737599
Fax 138274 0
Email 138274 0
a.mcmorland@auckland.ac.nz
Contact person for public queries
Name 138275 0
Jenna Salmons
Address 138275 0
Department of Exercise Sciences, University of Auckland, Newmarket, 1023, Private Bag 92019, Auckland
Country 138275 0
New Zealand
Phone 138275 0
+64 9 3737599
Fax 138275 0
Email 138275 0
jsal026@aucklanduni.ac.nz
Contact person for scientific queries
Name 138276 0
Jenna Salmons
Address 138276 0
Department of Exercise Sciences, University of Auckland, Newmarket, 1023, Private Bag 92019, Auckland
Country 138276 0
New Zealand
Phone 138276 0
+64 9 3737599
Fax 138276 0
Email 138276 0
jsal026@aucklanduni.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?
De-identified EEG and ECG data
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Any type
How or where can data be obtained?
Data will be published in the University of Auckland Institutional Figshare and can be obtained with the DOI or upon email request to the primary contact person- Jenna Salmons at jsal026@aucklanduni.ac.nz


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.