Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001420235
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
24/08/2018
Date last updated
2/08/2019
Date data sharing statement initially provided
2/08/2019
Date results provided
2/08/2019
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
NIL
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

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] 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
Active

Outcomes
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
None
Timepoint [1] 350763 0
None

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
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
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
16/04/2015
Date of last data collection
Anticipated
Actual
2/07/2015
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 20784 0
Denmark
State/province [1] 20784 0
Aalborg

Funding & Sponsors
Funding source category [1] 300425 0
Charities/Societies/Foundations
Name [1] 300425 0
New Zealand College of Chiropractic
Country [1] 300425 0
New Zealand
Primary sponsor type
Hospital
Name
Aalborg University Hospiatl
Address
Hobrovej 18-22, 9100 Aalborg,
Country
Denmark
Secondary sponsor category [1] 299886 0
None
Name [1] 299886 0
Address [1] 299886 0
Country [1] 299886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301227 0
North Denmark Region Committee on Health Research Ethics
Ethics committee address [1] 301227 0
Ethics committee country [1] 301227 0
Denmark
Date submitted for ethics approval [1] 301227 0
17/03/2014
Approval date [1] 301227 0
11/05/2015
Ethics approval number [1] 301227 0
N-20140027/N-20150033

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2975 2975 0 0
/AnzctrAttachments/375811-Danish ethics approval.pdf (Ethics approval)
Attachments [2] 2976 2976 0 0
/AnzctrAttachments/375811-2_SPINAL 26-2-2014_v3_protokol_17032014.pdf (Protocol)
Attachments [3] 2977 2977 0 0
/AnzctrAttachments/375811-4_SPINAL 26-2-2014_v3_healthy_english_17032014.pdf (Participant information/consent)
Attachments [4] 2978 2978 0 0
/AnzctrAttachments/375811-5_SPINAL 26-2-2014_v2_consent_english_17032014.pdf (Other)
Attachments [5] 3044 3044 0 0
/AnzctrAttachments/375811-Ethics approval letter (Pain EEG study).pdf (Ethics approval)
Attachments [6] 3045 3045 0 0
/AnzctrAttachments/375811-Pain EEG study protocol.pdf (Protocol)
Attachments [7] 3046 3046 0 0
/AnzctrAttachments/375811-Pain EEG study consent form.pdf (Participant information/consent)

Contacts
Principal investigator
Name 86302 0
Dr Imran Khan Niazi
Address 86302 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 86302 0
New Zealand
Phone 86302 0
+642102847764
Fax 86302 0
Email 86302 0
[email protected]
Contact person for public queries
Name 86303 0
Imran Niazi
Address 86303 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 86303 0
New Zealand
Phone 86303 0
+642102847764
Fax 86303 0
Email 86303 0
[email protected]
Contact person for scientific queries
Name 86304 0
Imran Niazi
Address 86304 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 86304 0
New Zealand
Phone 86304 0
+642102847764
Fax 86304 0
Email 86304 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
Data was collected in a Danish research lab so cannot be made publically available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.