Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001002673
Ethics application status
Approved
Date submitted
9/09/2014
Date registered
16/09/2014
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of chiropractic care on brain-computer interface interventions and rehabilitation
Scientific title
The effects of chiropractic care and brain computer interface interventions on neural plasticity in people with subclinical pain.
Secondary ID [1] 285303 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain injuries 292986 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293276 293276 0 0
Other physical medicine / rehabilitation
Musculoskeletal 293329 293329 0 0
Other muscular and skeletal disorders
Neurological 293330 293330 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will attend four intervention sessions for each outcome measure in random order. These sessions will include:
1. An experimental session where they will receive chiropractic care alone. Chiropractic care will involve a full spine adjusting session delivered by a registered chiropractor that will be approximately 15 minutes in duration.
2. An experimental session where they will receive a brain computer interface (BCI) intervention alone - this intervention involves the participant performing a motor imagination task where they picture a muscle movement taking place alone. No external device is used to apply the BCI intervention. This intervention will be approximately 15 minutes in duration and will be guided by a research assistant.
3. An experimental session where they will receive a chiropractic intervention followed by a BCI intervention as described above. This session will last approximately 30 minutes.
4. Control intervention
There will be a one week washout period between interventions.
Intervention code [1] 290212 0
Rehabilitation
Intervention code [2] 290243 0
Treatment: Other
Comparator / control treatment
A control session where they will receive no BCI intervention or adjustments but will be repositioned as if the chiropractor was going to adjust their spine (i.e. cervical, thoracic and lumbar adjustment setups). This will act as a physiological control for time, as well as the vestibular, cutaneous and muscular afferent discharge changes involved in moving and touching the subject when preparing for the adjustments. Care will be taken to ensure no forces are applied to individual segments during the control intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 293115 0
Transcranial magnetic stimulation measured using electromyography in a lower limb muscle.
Timepoint [1] 293115 0
Immediately post each intervention.
Primary outcome [2] 293158 0
Somatosensory evoked potentials measured using electroencephalogram.
Timepoint [2] 293158 0
Immediately post each intervention
Secondary outcome [1] 310387 0
Intramuscular and surface EMG will be used to record muscle activity in the lower limb (tibilais anterior muscle) when the participant is performing motor tasks (holding a small contraction for 10 seconds followed by a maximum voluntary contraction).
Timepoint [1] 310387 0
Immediately post each intervention

Eligibility
Key inclusion criteria
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 18-40, and have previously sought chiropractic care, and 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
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 limb disorder/dysfunction that would make them unable to carry out data recording sessions (e.g. sprain/strain/fracture), and if they have sought treatment for the subclinical pain symptoms.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2014
Actual
22/09/2014
Date of last participant enrolment
Anticipated
Actual
12/01/2018
Date of last data collection
Anticipated
Actual
29/03/2018
Sample size
Target
180
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 6343 0
New Zealand
State/province [1] 6343 0

Funding & Sponsors
Funding source category [1] 289923 0
University
Name [1] 289923 0
New Zealand College of Chiropractic
Country [1] 289923 0
New Zealand
Primary sponsor type
University
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mount Wellington
Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 288613 0
None
Name [1] 288613 0
Address [1] 288613 0
Country [1] 288613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291640 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 291640 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] 291640 0
New Zealand
Date submitted for ethics approval [1] 291640 0
Approval date [1] 291640 0
01/09/2014
Ethics approval number [1] 291640 0
14/NTB/113

Summary
Brief summary
It is possible that chiropractic care may enhance the efficiency and accuracy of BCI’s that are currently in development or operation. In this project we plan to investigate whether adjusting dysfunctional segments in the spine alters motor cortical output to the tibialis anterior muscle when it is applied in conjunction with a BCI intervention. If we find that spinal manipulation enhances BCI interventions this may be important for brain injury rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51298 0
Dr Imran Khan Niazi
Address 51298 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 51298 0
New Zealand
Phone 51298 0
+6495266789
Fax 51298 0
Email 51298 0
[email protected]
Contact person for public queries
Name 51299 0
Imran Khan Niazi
Address 51299 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 51299 0
New Zealand
Phone 51299 0
+6495266789
Fax 51299 0
Email 51299 0
[email protected]
Contact person for scientific queries
Name 51300 0
Imran Khan Niazi
Address 51300 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 51300 0
New Zealand
Phone 51300 0
+6495266789
Fax 51300 0
Email 51300 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.