Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001310651
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
16/12/2014
Date last updated
19/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic and brain activation
Scientific title
The effects of a single session of chiropractic care compared to passive movement on brain activity in people in pain and people not in pain.
Secondary ID [1] 285790 0
None
Universal Trial Number (UTN)
U1111-1164-8938
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 293680 0
Condition category
Condition code
Musculoskeletal 293978 293978 0 0
Other muscular and skeletal disorders
Neurological 294033 294033 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 294034 294034 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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] 290753 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
Active

Outcomes
Primary outcome [1] 293753 0
Electroencephalographic recording of activity in and between different regions of the brain.
Timepoint [1] 293753 0
Immediately post-intervention
Secondary outcome [1] 311757 0
None
Timepoint [1] 311757 0
None

Eligibility
Key inclusion criteria
Sixty participants will be recruited from the New Zealand College of Chiropractic community to participate in this study. Twenty will be pain free, 20 will be experiencing back or neck pain at the time of the study, and 20 subclinical spinal pain subjects will be recruited.

Participants may include students, staff, faculty, and previous patients of the College’s chiropractic centre. Subjects will be eligible for inclusion if they are English speaking, aged 18-50, and have previously sought chiropractic care. The pain group will be experiencing back or neck pain at the time that they participate in the trial. The subclinical pain group will have some history of recurring spinal dysfunction such as mild pain, ache, and/or stiffness with or without a history of known trauma.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be ineligible to participate if they exhibit no evidence of vertebral subluxations, have absolute contraindications to spinal adjustments, have 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
Treatment
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
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6508 0
New Zealand
State/province [1] 6508 0

Funding & Sponsors
Funding source category [1] 290350 0
Charities/Societies/Foundations
Name [1] 290350 0
Australian Spinal Research Foundation
Country [1] 290350 0
Australia
Funding source category [2] 290351 0
Charities/Societies/Foundations
Name [2] 290351 0
Hamblin Chiropractic Research Fund Trust
Country [2] 290351 0
New Zealand
Primary sponsor type
University
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Ellerslie
Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 289073 0
None
Name [1] 289073 0
Address [1] 289073 0
Country [1] 289073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292053 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 292053 0
Ethics committee country [1] 292053 0
New Zealand
Date submitted for ethics approval [1] 292053 0
05/12/2014
Approval date [1] 292053 0
19/01/2015
Ethics approval number [1] 292053 0

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

Contacts
Principal investigator
Name 53278 0
Dr Imran Niazi
Address 53278 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 53278 0
New Zealand
Phone 53278 0
+6495266789
Fax 53278 0
Email 53278 0
[email protected]
Contact person for public queries
Name 53279 0
Imran Niazi
Address 53279 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 53279 0
New Zealand
Phone 53279 0
+6495266789
Fax 53279 0
Email 53279 0
[email protected]
Contact person for scientific queries
Name 53280 0
Imran Niazi
Address 53280 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 53280 0
New Zealand
Phone 53280 0
+6495266789
Fax 53280 0
Email 53280 0
[email protected]

No information has been provided regarding IPD availability


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.