Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000880640
Ethics application status
Approved
Date submitted
12/08/2014
Date registered
19/08/2014
Date last updated
19/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of chiropractic care on trunk muscle function.
Scientific title
The effects of a single session of chiropractic care compared to passive movements on trunk muscle reflex function in individuals with recurrent low back pain.
Secondary ID [1] 285156 0
None
Universal Trial Number (UTN)
U111111581513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 292746 0
Condition category
Condition code
Musculoskeletal 293038 293038 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293072 293072 0 0
Other physical medicine / rehabilitation
Neurological 293073 293073 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will attend two intervention sessions in random order, one will be an experimental session where they will receive chiropractic care, and the other will be a control session where they will receive no 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. 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 with at least ten years clinical experience. Each intervention session will take approximately 1 hour and there will be a minimum 1 week washout period between each session.
Intervention code [1] 290004 0
Prevention
Intervention code [2] 290036 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.
Control group
Active

Outcomes
Primary outcome [1] 292902 0
Onset of muscle activation during postural perturbations (feed forward activation) will be measured using electromyography (EMG) and will be the primary outcome measure.
Timepoint [1] 292902 0
Immediately post-intervention
Secondary outcome [1] 309898 0
The secondary outcome measure will be muscle reflex latency following force release in trunk flexion, extension, and lateral bending. This will be will be measured using electromyography (EMG)
Timepoint [1] 309898 0
Immendiately post-intervention.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they are English speaking, aged 18-50, have a history of recurring low back pain, and display evidence of delayed feed forward activation times for abdominal muscles compared to deltoid.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants 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 current LBP.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 6291 0
New Zealand
State/province [1] 6291 0
Auckland

Funding & Sponsors
Funding source category [1] 289758 0
Other
Name [1] 289758 0
New Zealand College of Chiropractic
Country [1] 289758 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mount Wellington
Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 288447 0
None
Name [1] 288447 0
Address [1] 288447 0
Country [1] 288447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291487 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 291487 0
Ethics committee country [1] 291487 0
New Zealand
Date submitted for ethics approval [1] 291487 0
18/06/2014
Approval date [1] 291487 0
16/07/2014
Ethics approval number [1] 291487 0
14/NTB/84

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

Contacts
Principal investigator
Name 50650 0
Dr Heidi Haavik
Address 50650 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 50650 0
New Zealand
Phone 50650 0
+6495266789
Fax 50650 0
Email 50650 0
[email protected]
Contact person for public queries
Name 50651 0
Heidi Haavik
Address 50651 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 50651 0
New Zealand
Phone 50651 0
+6495266789
Fax 50651 0
Email 50651 0
[email protected]
Contact person for scientific queries
Name 50652 0
Heidi Haavik
Address 50652 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
Country 50652 0
New Zealand
Phone 50652 0
+6495266789
Fax 50652 0
Email 50652 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.