Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000175976
Ethics application status
Approved
Date submitted
30/01/2020
Date registered
17/02/2020
Date last updated
1/07/2021
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of single chiropractic spinal manipulation on brain activity
Scientific title
Impact of specific vs non-specific high-velocity low-amplitude spinal manipulations on sensorimotor integration in chiropractic care in participants with neck pain, ache or stiffness
Secondary ID [1] 300258 0
Nill
Universal Trial Number (UTN)
U1111-1243-9874
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical spinal pain 315825 0
Neck pain 315826 0
Condition category
Condition code
Alternative and Complementary Medicine 314112 314112 0 0
Other alternative and complementary medicine
Musculoskeletal 314113 314113 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 314114 314114 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a specific adjustment to the cervical spine using an Activator Instrument. Before the intervention, the principal investigator will first screen all the participants for inclusion. Then, a registered chiropractor will check for subluxated cervical segments. Eligible participants will attend a single data collection session lasting approximately an hour. Following inclusion, a pre-intervention assessment of somatosensory evoked potentials (SEP) will be undertaken by the principal investigator to assess the sensorimotor integration. The pre-intervention assessment will involve the application of electrical stimulation over the participant's wrist, to stimulate the median nerve, as they focus their gaze on a fixed target on the wall. During the stimulation, 1000 SEPs will be recorded via electroencephalography (EEG) cap placed on the participant's head. The chiropractor will then deliver the intervention comprising of specific high velocity, low amplitude spinal manipulation (HVLASM) to the cervical spine with the Activator Instrument. HVLASM is a form of manual therapy commonly used by chiropractors to restore the movement of the spinal joints. It is to emphasise here, that only one thrust will be applied. The activator instrument is a hand-held device that delivers fast, precise and low-force adjustment to the spine. Its use reduces the amount of variability in the thrust amplitude and duration. Overall, the specific HVLASM intervention will take five minutes. Immediately after the intervention, the participant's SEP will be re-assessed. All the assessments and intervention will be delivered as the participant comfortably sits on a chair.
Intervention code [1] 316527 0
Treatment: Other
Comparator / control treatment
The specific HVLASM intervention will be compared with non-specific HVLASM where in contrast to the specific group receiving an adjustment related to the dysfunctional spine, the non-specific group will receive a HVLASM on an adjacent, non-dysfunctional vertebra. It is hereby important to mention, that the non-dysfunctional vertebra adjusted is always the one being the furthest away from the dysfunctional-vertebra. The non-specific HVLASM will also take approximately five minutes.
Control group
Active

Outcomes
Primary outcome [1] 322498 0
SEP-recordings of the somatosensory cortex which are assessed using EEG.
Timepoint [1] 322498 0
Before the intervention (pre-intervention) and immediately after the intervention (post-intervention)
Secondary outcome [1] 378807 0
Nill
Timepoint [1] 378807 0
Nill

Eligibility
Key inclusion criteria
All individuals with subclinical pain between the age of 18 and 50 years will be eligible. Individuals with subclinical pain defines them as having no severe pain-related problems but with the occurrence of repeating neurophysiological dysfunction such as mild neck pain, ache or stiffness. Participants may include students, staff, faculty, and previous patients of the college’s chiropractic centre. Participants will be eligible for inclusion if they are English speaking and have previously sought chiropractic care.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with subclinical pain having no detectable subluxation on the experimental day will be excluded. Other exclusion criteria are: people with a cardiac pacemaker or any metal plates on their skull and those who have had received chiropractic treatment less than a week before the experiment day.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2020
Actual
19/02/2020
Date of last participant enrolment
Anticipated
18/02/2021
Actual
20/03/2020
Date of last data collection
Anticipated
1/04/2021
Actual
23/03/2020
Sample size
Target
90
Accrual to date
Final
96
Recruitment outside Australia
Country [1] 22220 0
New Zealand
State/province [1] 22220 0
Auckland

Funding & Sponsors
Funding source category [1] 304682 0
University
Name [1] 304682 0
New Zealand College of Chiropractic
Country [1] 304682 0
New Zealand
Primary sponsor type
University
Name
New Zealand College of Chiropractic
Address
6 Harrison Road, Mt. Wellington 1060, Auckland
Country
New Zealand
Secondary sponsor category [1] 304991 0
None
Name [1] 304991 0
Address [1] 304991 0
Country [1] 304991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305103 0
Health and Disability Ethics Committee
Ethics committee address [1] 305103 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 305103 0
New Zealand
Date submitted for ethics approval [1] 305103 0
22/11/2019
Approval date [1] 305103 0
20/12/2019
Ethics approval number [1] 305103 0
Ethics ref: 19/CEN/202

Summary
Brief summary
This study endeavours to investigate how a single specific vs. non-specific chiropractic spinal manipulation changes brain activity. Therefore, the study hypothesis is that there is no difference between a specific versus a non-specific chiropractic spinal manipulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99278 0
Dr Imran Khan Niazi
Address 99278 0
Organisation: New Zealand College of Chiropractic
Street: 6 Harrison Road
Suburb/Town: Mount Wellington, Auckland
Postcode: 1060
Country: New Zealand
Country 99278 0
New Zealand
Phone 99278 0
+6495266789
Fax 99278 0
Email 99278 0
[email protected]
Contact person for public queries
Name 99279 0
Dr Imran Khan Niazi
Address 99279 0
Organisation: New Zealand College of Chiropractic
Street: 6 Harrison Road
Suburb/Town: Mount Wellington, Auckland
Postcode: 1060
Country: New Zealand
Country 99279 0
New Zealand
Phone 99279 0
+6495266789
Fax 99279 0
Email 99279 0
[email protected]
Contact person for scientific queries
Name 99280 0
Dr Imran Khan Niazi
Address 99280 0
Organisation: New Zealand College of Chiropractic
Street: 6 Harrison Road
Suburb/Town: Mount Wellington, Auckland
Postcode: 1060
Country: New Zealand
Country 99280 0
New Zealand
Phone 99280 0
+6495266789
Fax 99280 0
Email 99280 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.