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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Chiropractic Care on tonic pain assessed via EEG in subclinical population
Scientific title
The effects of altered spinal afferentation on central processing of tonic pain - a pilot study using standardized low-resolution brain electromagnetic tomography (sLORETA)
Secondary ID [1] 295829 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subclinical spinal pain 309273 0
Condition category
Condition code
Alternative and Complementary Medicine 308146 308146 0 0
Other alternative and complementary medicine
Musculoskeletal 308147 308147 0 0
Other muscular and skeletal disorders

Study type
Description of intervention(s) / exposure
The participants will attend two intervention sessions in random order. The experimental intervention will be a single session of chiropractic care. Full spine adjustments will be carried out during the experimental session. The entire spine and sacroiliac joints will be assessed for vertebral subluxations and adjusted where deemed necessary by a registered chiropractor. The intervention will take approximately 10 minutes to carry out. There will be a 1 week washout period between the 2 interventions.
Intervention code [1] 312162 0
Treatment: Other
Comparator / control treatment
The control intervention will consist of passive and active movements of the subject’s head, spine and body that will be carried out by the same chiropractor who pre-checks the participants for vertebral subluxations and who performs the adjustments in the experimental intervention session. This control intervention will involve the participants being moved into the adjustment setup positions where the chiropractor would normally apply a thrust to the spine to achieve the adjustments. However, the experimenter will be particularly careful not to put pressure on any individual spinal segments. Loading a joint, as is done prior to spinal adjustments has been shown to alter paraspinal proprioceptive firing in anesthetised cats (Pickar & Wheeler, 2001), and will therefore be carefully avoided by ending the movement prior to end range- of-motion when passively moving the participants. No spinal adjustments will be performed during any control intervention. This control intervention is not intended to act as a sham adjustment but to
act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input that will occur with the type of passive and active movements involved in preparing a patient for an adjustment. It also acts as a control for the effects of the stimulation necessary to collect the dependent measures of the study, and acts as a control for the time required to carry out the adjustment intervention. The control intervention will take approximately 10 minutes to complete.
Control group

Primary outcome [1] 307121 0
As it's an exploratory study so, electroencephalographic recording of activity in and between different regions of the brain will be assessed.
Timepoint [1] 307121 0
Immediately post-intervention
Secondary outcome [1] 350763 0
Timepoint [1] 350763 0

Key inclusion criteria
15 subclinical participants were recruited from the Aalborg University Hospital, Denmark to participate in this study.
Minimum age
18 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Subjects were ineligible to participate if they exhibit no evidence of vertebral subluxations, have absolute contraindications to spinal adjustments, had experienced previous significant adverse reactions to chiropractic care, or they are suffering from a current upper or lower limb disorder/dysfunction that would make them unable to carry out data recording sessions (e.g. sprain/strain/fracture).

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 20784 0
State/province [1] 20784 0

Funding & Sponsors
Funding source category [1] 300425 0
Name [1] 300425 0
New Zealand College of Chiropractic
Address [1] 300425 0
6 Harrison Road
Auckland 1060
Country [1] 300425 0
New Zealand
Primary sponsor type
Aalborg University Hospiatl
Hobrovej 18-22, 9100 Aalborg,
Secondary sponsor category [1] 299886 0
Name [1] 299886 0
Address [1] 299886 0
Country [1] 299886 0

Ethics approval
Ethics application status
Ethics committee name [1] 301227 0
North Denmark Region Committee on Health Research Ethics
Ethics committee address [1] 301227 0
Niels Bohrs Road 30
9220 Aalborg East
Ethics committee country [1] 301227 0
Date submitted for ethics approval [1] 301227 0
Approval date [1] 301227 0
Ethics approval number [1] 301227 0

Brief summary
Over the past decade, there has been growing evidence to suggest that chiropractic care influences brain function. The researchers that have done this work have used sophisticated brain research methods such as measuring brain waves using electroencephalography (EEG). These studies have shown that adjusting vertebral subluxation in the spine alters function in various brain structures. However, the evidence for the involvement of these brain structures is indirect.
Recently efforts have been made to improve the spatial resolution of EEG using a new EEG technique, known as multichannel matching pursuit technique. With this technique, it is possible to determine with greater clarity wherein the brain activity occurs. We intend to use this new technique to explore which structures in the brain are talking to each other before, and after, chiropractic adjustments.
By completing this study, the researchers hope to gain a much better understanding of how vertebral subluxations and adjustments affect nervous system function
Trial website
Trial related presentations / publications
1)Dishabituation of the central nervous system to tonic pain following chiropractic care - a standardized low-resolution brain electromagnetic tomography (sLORETA) based study. / Navid, Muhammad Samran; Lelic, Dina; Niazi, Imran Khan; Holt, Kelly; Bolvig, Esben; Drewes, Asbjorn Mohr, Haavik, Heidi. In World Federation of Chiropractic (WFC) 14th Biennial Conference March 2017; Washington, USA
2)26. Dishabituation of the central nervous system to tonic pain following chiropractic care: a standardized low-resolution brain electromagnetic tomography (sLORETA) based study. / Navid, Muhammad Samran; Lelic, Dina; Niazi, Imran Khan; Holt, K.; Mark, Esben Bolvig; Drewes, Asbjørn; Haavik, H. 46th Annual Meeting of the Society for Neuroscience, Neuroscience 2016, 12-16 November 2016, San Diego, CA, USA. Society for Neuroscience, 2016. 428.11 / LL1.
Public notes
Attachments [1] 2975 2975 0 0
Attachments [2] 2976 2976 0 0
Attachments [3] 2977 2977 0 0
Attachments [4] 2978 2978 0 0
Attachments [5] 3044 3044 0 0
Attachments [6] 3045 3045 0 0
Attachments [7] 3046 3046 0 0
/AnzctrAttachments/375811-Pain EEG study consent form.pdf (Participant information/consent)

Principal investigator
Name 86302 0
Dr Imran Khan Niazi
Address 86302 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Country 86302 0
New Zealand
Phone 86302 0
Fax 86302 0
Email 86302 0
Contact person for public queries
Name 86303 0
Dr Imran Niazi
Address 86303 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Country 86303 0
New Zealand
Phone 86303 0
Fax 86303 0
Email 86303 0
Contact person for scientific queries
Name 86304 0
Dr Imran Niazi
Address 86304 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Country 86304 0
New Zealand
Phone 86304 0
Fax 86304 0
Email 86304 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Data was collected in a Danish research lab so cannot be made publically available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Journal publication details
Publication date and citation/details [1] 3646 0
The study was published on 06 May 2019
Navid, M. S., Lelic, D., Niazi, I. K., Holt, K., Mark, E. B., Drewes, A. M., & Haavik, H. (2019). The effects of chiropractic spinal manipulation on central processing of tonic pain - a pilot study using standardized low-resolution brain electromagnetic tomography (sLORETA). Scientific Reports, 9(1), 1-12. [6925].
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary
The analysis of the data showed that the pain scores decreased by 9% after the control intervention while the unpleasantness scores decreased by 7% after both the control and chiropractic interventions. sLORETA showed decreased brain activity during tonic pain after the sham intervention, whereas no change in EEG activity was seen after the chiropractic spinal adjustment session. What this means is that the participants showed pain habituation following the sham intervention, which is expected and means they’re getting used to the pain. However, after being adjusted by the chiropractor, no habituation occurred. We think this may mean that chiropractic care may play a role in avoiding maladaptive neural plastic changes in the brain.