Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000145909
Ethics application status
Approved
Date submitted
15/01/2020
Date registered
12/02/2020
Date last updated
6/08/2021
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of Low Back Pain (LBP) and chiropractic on the motor control of the trunk
Muscle
Scientific title
Understanding spinal motor control during standing, locomotion and in response to an
external perturbation, in healthy people, sub clinical and low back pain subjects, a
chiropractic care study
Secondary ID [1] 300264 0
Nil known
Universal Trial Number (UTN)
U1111-1243-0131
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 315842 0
Sub-clinical back pain 315843 0
Condition category
Condition code
Alternative and Complementary Medicine 314125 314125 0 0
Other alternative and complementary medicine
Musculoskeletal 314342 314342 0 0
Other muscular and skeletal disorders
Neurological 314343 314343 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 15 minutes to carry out. The chiropractor will takes notes that will be used to monitor the intervention process and result.
Intervention code [1] 316541 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 anesthetized 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] 322513 0
Neurophysiological activity of the back muscles via the use of high density EMG recording and decomposition of those signals via the Convolution Kernel Compensation( Holobar et al., 2014)
Timepoint [1] 322513 0
Immediately post-intervention
Primary outcome [2] 322711 0
Neurophysiological activity of the abdominal muscles via the use of 4 classic EMG recording (right and left side of the rectus abdominis muscle, and right external oblique and left external oblique)
Timepoint [2] 322711 0
Immediately post-intervention
Primary outcome [3] 322712 0
Motion capture data via the use of a Vicon motion capture system of 14 infra red camera and passive reflective markers. Clusters of markers will be used to collect the data for the spine segments.
Timepoint [3] 322712 0
Immediately post-intervention
Secondary outcome [1] 378767 0
[Primary outcome] Force reaction data collected from the force plate incorporated in the instrumented treadmill that is used in this experiment
Timepoint [1] 378767 0
Immediately post-intervention

Eligibility
Key inclusion criteria
30 subjects will be recruited in each of the three groups, via advertising within the New Zealand College of Chiropractic community. Participants may include students, staff, faculty, and previous patients of the College’s chiropractic center and also family, friends and acquaintances of the New Zealand College of Chiropractic community. Subjects must be English speaking and aged 18-50.
The inclusion criteria for the NSLBP group is to present a non-specific LBP. LBP being defined by a pain located between the lower rib margins and the buttock crease and for which the pathoanatomical cause of the pain is not determined. To be part of the sub-clinical group a subject must have had some history of recurring spinal dysfunction such as mild pain, ache, and/or stiffness with or without a history of know trauma.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the LBP and sub-clinical group will be an identifiable cause for the LBP. Subjects will also be ineligible to participate if they exhibit no evidence of vertebral subluxations, have absolute contraindications to spinal adjustment, have experienced previous significant adverse reactions to chiropractic care, or they are suffering from a current lower limb disorder/dysfunction that would make them unable to carry out data recording sessions (e.g. severe sprain/strain/fracture). Individuals with a recent history of inner ear infection with associated balance or coordination problem, a history of cerebral trauma with unresolved neurosensory symptoms, a recent history of vestibular disorder, previous spinal surgery, an involvement in specific balance or stabilization training in the 6 months before testing, and those taking pain medication will be excluded. The low back pain must have been present at least 3 months in the last year to be counted as chronic. In addition, the subclinical subjects must be at a maximum of 2 out of 10 on the pain scale during the day of the data collection.

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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
10/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 22222 0
New Zealand
State/province [1] 22222 0
Auckland

Funding & Sponsors
Funding source category [1] 304687 0
Charities/Societies/Foundations
Name [1] 304687 0
New Zealand College of Chiropractic
Country [1] 304687 0
New Zealand
Funding source category [2] 304688 0
University
Name [2] 304688 0
Université polytechnique des Hauts-de-France
Country [2] 304688 0
France
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Ellerslie
Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 304996 0
University
Name [1] 304996 0
Université polytechnique des Hauts-de-France
Address [1] 304996 0
Voirie Communal
Université Val Mont Houy
Famars 59300
Country [1] 304996 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305108 0
Health and Disability Ethics Committees
Ethics committee address [1] 305108 0
Ethics committee country [1] 305108 0
New Zealand
Date submitted for ethics approval [1] 305108 0
12/11/2019
Approval date [1] 305108 0
13/12/2019
Ethics approval number [1] 305108 0

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

Contacts
Principal investigator
Name 99290 0
Dr Imran Khan Niazi
Address 99290 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 99290 0
New Zealand
Phone 99290 0
+64 2102847764
Fax 99290 0
Email 99290 0
[email protected]
Contact person for public queries
Name 99291 0
Imran Khan Niazi
Address 99291 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 99291 0
New Zealand
Phone 99291 0
+64 2102847764
Fax 99291 0
Email 99291 0
[email protected]
Contact person for scientific queries
Name 99292 0
Imran Khan Niazi
Address 99292 0
New Zealand College of Chiropractic
6 Harrison Road Ellerslie
Auckland
1060
Country 99292 0
New Zealand
Phone 99292 0
+64 2102847764
Fax 99292 0
Email 99292 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.