Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000725662
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic adjustment and brain, eyes and heart activity
Scientific title
Effects of chiropractic adjustments on autonomic nervous system function in adults with subclinical spinal pain: A pilot randomized controlled trial assessing prefrontal cortex activity, pupil changes, and heart rate variability.
Secondary ID [1] 309266 0
Nil known
Universal Trial Number (UTN)
U1111-1290-0994
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Stress 329418 0
Condition category
Condition code
Neurological 326363 326363 0 0
Studies of the normal brain and nervous system
Cardiovascular 326364 326364 0 0
Normal development and function of the cardiovascular system
Eye 326365 326365 0 0
Normal eye development and function
Alternative and Complementary Medicine 326368 326368 0 0
Other alternative and complementary medicine
Musculoskeletal 327276 327276 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chiropractic Intervention:
The entire spine and both sacroiliac joints will be assessed for vertebral subluxations and adjusted where deemed necessary by an experienced chiropractor of minimum 10 years’ experience. The clinical indicators of vertebral subluxations include tenderness to palpation of the relevant joints, manual palpation for restricted intersegmental range of motion, palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. These clinical indicators are routinely used by chiropractors when analysing the spine and have previously been shown to be reliable for the identification of vertebral subluxations when used as a multidimensional battery of tests. Any chiropractic spinal adjustments will involve a high-velocity low-amplitude thrust, a standard chiropractic technique, to sites deemed to have vertebral subluxations as identified using the indicators above. These adjusting techniques have been previously used in studies that have investigated neurophysiological effects of spinal adjustments [for review see Haavik et al., 2021]. The chiropractic intervention will be delivered in a single session and will take around 10 minutes.
Before and after the chiropractic or control intervention, participants will perform alternating trials of immersing their hands in cold water and performing a mental arithmetic task (Maastricht Acute Stress Test).
Intervention code [1] 325699 0
Treatment: Other
Comparator / control treatment
Control intervention:
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. 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. The control intervention will be delivered in a single session and will take around 10 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 334218 0
Neural activation patterns measured using Functional near-infrared spectroscopy (fNIRS)
Timepoint [1] 334218 0
Before, during and after the Maastricht Acute Stress Test at baseline and post-assessment (immediately following chiropractic/control session).
Secondary outcome [1] 419867 0
Heart rate variability measured using PowerLab ECG
Timepoint [1] 419867 0
Before, during and after the Maastricht Acute Stress Test at baseline and post-assessment post-assessment (immediately following chiropractic/control session).
Secondary outcome [2] 419868 0
Subjective stress using 11-point stress numeric rating scale (SNRS-11)
Timepoint [2] 419868 0
Before, during and after the Maastricht Acute Stress Test at baseline and post-assessment (immediately following chiropractic/control session).
Secondary outcome [3] 419869 0
Pupil diameter using gazepoint eye tracker
Timepoint [3] 419869 0
Before, during and after the Maastricht Acute Stress Test at baseline and post-assessment (immediately following chiropractic session).
Secondary outcome [4] 419871 0
Feasibility measures:
1) Recruitment assessed via study recruitment logs.
2.) Protocol compliance, protocol deviation, protocol adherence, protocol fidelity, data completeness, participant retention assessed via audit of data collection records.
3) Protocol acceptability to participants and chiropractor assessed via open-ended questions specifically designed for this study.
4.) Responsiveness of measures using data analysis techniques.
Timepoint [4] 419871 0
Upon conclusion of the study: recruitment, retention, data completeness, responsiveness of measures.
During the study: protocol compliance, protocol deviation, protocol adherence, protocol fidelity, protocol acceptability to participants and chiropractor. This will be recorded at each data collection session throughout the study.

Eligibility
Key inclusion criteria
Individuals aged between 18 and 50 years with subclinical spinal pain (SCSP) will be recruited. SCSP refers to individuals who have a previous history of recurring spinal (e.g., neck, mid-back or low back) pain, ache, or tension, that is not always present, that they have not yet sought any treatment for, and may or may not be accompanied with a history of spinal injury. The participants will be included if they have no or mild symptoms on the day of the experiment (i.e., less than 3/10 on the numeric pain rating scale) and have not received any chiropractic adjustment or any other manual therapy in the past two weeks of their data collection session.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosed dysautonomia and Raynaud's disease.
- Have any contraindications to chiropractic adjustments (such as a history of recent spinal fractures; inflammatory disease; or recent cancer).
- Have any damage to your eyes (such as coloboma or oculomotor palsy).
- Have cardiovascular diseases, hypertension (including fully controlled hypertension), severe physical illnesses (e.g., Fibromyalgia) or endocrine disorders.
- Have any pre-existing neurophysiological or psychological conditions.
- Are currently managing any acute or chronic pain conditions.
- Are taking any medications known to affect the HPA axis such as corticosteroids.
- Vape or smoke cigarette (more than 10 smokes/day).
- Are pregnant.

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)
Following recruitment, screening and informed consent, eligible participants will be randomly allocated to either intervention or control group using a randomisation schedule generated by a computer system. This will be held by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation stratified by age and gender
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
Statistical methods / analysis
fNIRS signals (HbO2) will be pre-processed using a moving average filter of one second in duration and then corrected for blood volume as previously proposed. For each signal modality, the first five samples will be averaged and then subtracted from the signal to remove any offset and bring the starting point to zero. Thereafter, the minimum value (mHbO2) will be computed as an indication of maximum oxygen consumption. For descriptive reporting of outcomes, means and standard deviations will be used if the outcome is normally distributed otherwise medians along with inter-quartile ranges will used. For statistical evaluation of differences across groups and changes across time, linear mixed or generalized linear mixed regression models will be setup for continuous outcomes and ordinal mixed regression models for ordinal outcomes. All these models will have a longitudinal analysis of covariance structure in which post-intervention outcome means and odds ratios will be estimated while accounting for pre-intervention values. Moreover, within-participant correlations arising from repeat measurements will be controlled for by estimating participant-wise random intercepts and/or participant-wise slopes across time. The choice of the final model structure will be decided by minimizing information loss quantified by Akaike’s Information Criterion (AIC). Effect sizes for baseline adjusted between-group differences and within-group changes over time estimated from the models will be reported along their 95% confidence intervals. A sample size calculation for a full scale RCT will be reported with varying parameters such as number of sessions, intra-cluster correlation, dropout-rate, proportion of within-participant missing values, proportion of protocol deviations, etc. The causes of missing values and protocol deviations will be carefully analysed and reported. In the case of significant missing values and/or protocol deviations (> 5%), an assumption free primary analysis on the intention to treat dataset will be reported along with best-case worst-case analyses. The feasibility issues will be evaluated through percentage where applicable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
30/08/2023
Actual
Date of last data collection
Anticipated
17/10/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25340 0
New Zealand
State/province [1] 25340 0
Auckland

Funding & Sponsors
Funding source category [1] 313458 0
Other
Name [1] 313458 0
New Zealand College of Chiropractic
Country [1] 313458 0
New Zealand
Funding source category [2] 313462 0
Charities/Societies/Foundations
Name [2] 313462 0
Australian Spinal Research Foundation
Country [2] 313462 0
Australia
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mount Wellington
Auckland
New Zealand
1060
Country
New Zealand
Secondary sponsor category [1] 316001 0
None
Name [1] 316001 0
Address [1] 316001 0
Country [1] 316001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312658 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 312658 0
Ethics committee country [1] 312658 0
New Zealand
Date submitted for ethics approval [1] 312658 0
22/03/2023
Approval date [1] 312658 0
28/06/2023
Ethics approval number [1] 312658 0

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

Contacts
Principal investigator
Name 125454 0
Dr Nitika Kumari
Address 125454 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
New Zealand
Country 125454 0
New Zealand
Phone 125454 0
+64 273707917
Fax 125454 0
Email 125454 0
[email protected]
Contact person for public queries
Name 125455 0
Nitika Kumari
Address 125455 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
New Zealand
Country 125455 0
New Zealand
Phone 125455 0
+64 273707917
Fax 125455 0
Email 125455 0
[email protected]
Contact person for scientific queries
Name 125456 0
Nitika Kumari
Address 125456 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
New Zealand
Country 125456 0
New Zealand
Phone 125456 0
+64 273707917
Fax 125456 0
Email 125456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.