Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001040651
Ethics application status
Approved
Date submitted
28/08/2014
Date registered
26/09/2014
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of chiropractic care on the H-reflex
Scientific title
The effect of six weeks of chiropractic care on the H-reflex in adults with a history of recurring spinal dysfunction
Secondary ID [1] 285131 0
Nill
Universal Trial Number (UTN)
U111111513843
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subclinical spinal pain 292693 0
Condition category
Condition code
Alternative and Complementary Medicine 293010 293010 0 0
Other alternative and complementary medicine
Musculoskeletal 293313 293313 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293314 293314 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Full spine adjustments will be carried out during the experimental sessions. 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. The vertebral subluxation indicators that will be used to assess the function of the spine prior to and after each spinal adjustment intervention include assessing for tenderness to palpation of the relevant joints, manually palpating for restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. All of these biomechanical characteristics are known clinical indicators of spinal dysfunction (Fryer, Morris, & Gibbons, 2004; Hestboek & Leboeuf-Yde, 2000). These findings will be documented prior to and after each spinal adjustment intervention. The improvements in segmental function following spinal adjustments will also be recorded for each subject. Subjects will attend 2-3 adjustment sessions a week for 6 weeks with each session lasting 10 minutes on average. The adjustment schedule will be determined by the chiropractor who is providing care to the participant.
Intervention code [1] 289983 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 sessions. 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 and will only be applied between the pre and post assessment tests on the days that the participants undergo the neurophysiological testing. During the rest of the control period participants will be able to engage in their usual health care activities, apart from receiving chiropractic care. The full control period will last 6 weeks, during which the participants will receive the control intervention at baseline, 3 weeks and 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 292867 0
H-reflex recordings which are assessed using electromyography
Timepoint [1] 292867 0
At baseline and Pre and post the 6 week intervention component and the 6 week control component.
Primary outcome [2] 293215 0
M wave recruitment curve recordings which are assessed using electromyography
Timepoint [2] 293215 0
At baseline and Pre and post the 6 week intervention component and the 6 week control component.
Secondary outcome [1] 309843 0
V-wave recordings which are assessed using electromyography
Timepoint [1] 309843 0
At baseline and Pre and post the 6 week intervention component and the 6 week control component.

Eligibility
Key inclusion criteria
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 lower 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
Suspended
Date of first participant enrolment
Anticipated
29/09/2014
Actual
1/11/2015
Date of last participant enrolment
Anticipated
25/12/2019
Actual
25/02/2016
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
32
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 6285 0
New Zealand
State/province [1] 6285 0
Auckland

Funding & Sponsors
Funding source category [1] 289738 0
University
Name [1] 289738 0
NewZealand College of chiropractic
Country [1] 289738 0
New Zealand
Primary sponsor type
University
Name
NewZealand College of chiropractic
Address
6 Harrison road
Ellerslie
1060,Auckland
Country
New Zealand
Secondary sponsor category [1] 288431 0
None
Name [1] 288431 0
Address [1] 288431 0
Country [1] 288431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291473 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291473 0
Ethics committee country [1] 291473 0
New Zealand
Date submitted for ethics approval [1] 291473 0
16/12/2013
Approval date [1] 291473 0
01/02/2014
Ethics approval number [1] 291473 0
Ethics ref: 13/NTA/237

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

Contacts
Principal investigator
Name 50562 0
Dr Heidi Haavik
Address 50562 0
New Zealand College of Chiropractic 6 Harrison Road Ellerslie Auckland
1060
Country 50562 0
New Zealand
Phone 50562 0
+6495266789
Fax 50562 0
Email 50562 0
[email protected]
Contact person for public queries
Name 50563 0
Heidi Haavik
Address 50563 0
New Zealand College of Chiropractic 6 Harrison Road Ellerslie Auckland
1060
Country 50563 0
New Zealand
Phone 50563 0
+6495266789
Fax 50563 0
Email 50563 0
[email protected]
Contact person for scientific queries
Name 50564 0
Heidi Haavik
Address 50564 0
New Zealand College of Chiropractic 6 Harrison Road Ellerslie Auckland
1060
Country 50564 0
New Zealand
Phone 50564 0
+6495266789
Fax 50564 0
Email 50564 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo no results to report yet

Documents added automatically
No additional documents have been identified.