Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001191886
Ethics application status
Approved
Date submitted
19/09/2020
Date registered
6/09/2021
Date last updated
6/09/2021
Date data sharing statement initially provided
6/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized pilot trial evaluating the effect of One to Zero (OTZ) chiropractic technique on brain function and health in adults with neck dysfunction
Scientific title
The effect of the OTZ chiropractic technique on brain function and health in adults with atlantooccipital joint dysfunction: A randomized control trial
Secondary ID [1] 302234 0
Nil
Universal Trial Number (UTN)
U1111-1258-3236
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck dysfunction 318936 0
Sensorimotor dysfunction 318937 0
Impaired head and neck proprioception 318938 0
Atlantooccipital joint dysfunction 318939 0
Impaired health and well-being 318940 0
Autonomic dysfunction 321923 0
Impaired mobility 321924 0
Condition category
Condition code
Musculoskeletal 316909 316909 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 316910 316910 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a chiropractic technique, known as the One-to-Zero (OTZ) tension adjustment. OTZ treatment begins with correction of articular dysfunction between the occiput (C0) and the atlas, first cervical (C1) via a high velocity low amplitude manipulation (HVLA) technique. This technique first addresses decreased functional mobility between the C0-C1 joint, via high velocity, low amplitude manipulative thrusts. Other areas of cervicothoracic joint dysfunction are also treated with a specific HVLA protocol, if clinically indicated. These include the upper thoracic and lumbar spine, if these areas show clinical evidence of joint dysfunction (e.g. restricted segmental range of motion, local tenderness, etc..). A registered chiropractor with expertise and advanced training in the OTZ technique will provide the treatment. The OTZ treatment will be personalized to each individual in the treatment arm since this cluster may comprise of acute and/or chronic cases, and different areas of associated joint dysfunction. Individuals in the treatment group will receive chiropractic care with the OTZ treatment for a total of 4 to 6 visits (2 to 3 visits a week for an average of 2 to 3 weeks), dependent on the severity and chronicity of each participant’s joint dysfunction(s). The number of required visits for each participant is decided by the chiropractor providing the treatment, who will use their clinical judgement to make this decision. Each treatment session will be approximately 15 minutes in duration with the first session being at least 45 minutes, to acquire details about their medical history and perform a physical examination and assessment of C0 – C1 joint complex and areas of cervicothoracic spinal dysfunction. The OTZ treatment will be performed at the chiropractic clinic where the registered chiropractor administering the treatment practices. In order to monitor adherence to the intervention, the chiropractor will provide the researchers with a list of participants and number of treatment sessions that were attended over the intervention period.
Intervention code [1] 318523 0
Rehabilitation
Intervention code [2] 320545 0
Treatment: Other
Comparator / control treatment
The comparator/control group will be part of a wait-list control group. The individuals in this group will undergo baseline testing, followed by a two-week wait period, (a similar duration to the treatment group’s treatment duration). The change in outcome measures (i.e. difference between follow-up and baseline) will be compared between this group and the treatment group. This will enable us to compare the effectiveness of OTZ treatment in outcome measures (related to motor control, autonomic function, awareness of head and neck position as well as general health and well-being). The control group will be offered treatment once they have had their follow-up measures collected.
Control group
Active

Outcomes
Primary outcome [1] 325016 0
Neuromuscular function of Neck Muscles:
Force sensors and surface electromyography will be used to capture the force output and electrical activity during a maximal voluntary contraction of the upper trapezius and sternocleidomastoid muscle, respectively.
Timepoint [1] 325016 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Primary outcome [2] 325017 0
Head repositioning accuracy

The ability to accurately reproduce different head positions (i.e. neutral head position and target head position) will be measured using a cervical range of motion (C-ROM) device, while participant’s vision is occluded so that the participant has to rely on proprioception.
Timepoint [2] 325017 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Primary outcome [3] 325018 0
Physiological outcome measure

Surface electromyography electrodes will be placed at the mid-clavicular region on the upper aspect of the participant’s chest (right and left side). A ground strap will be wrapped around the participant’s left wrist. This will be connected to a Powerlab 26T (AD Instruments Inc., Sydney, Australia). This set-up allows for the simultaneous recording of heart rate (beats per a minute) and assessment of heart rate variability (timing between adjacent heart beats).
Timepoint [3] 325018 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [1] 386553 0
Neck ROM:
A cervical range of motion device will be used to measure the degrees of neck movement in the three planes – Sagittal (front, back), Coronal (left and right lateral flexion) and transverse (right and left rotation). This is a primary outcome, which seeks to examine improvements in neck mobility.
Timepoint [1] 386553 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [2] 395502 0
Shoulder ROM:
Shoulder abduction, flexion and extension will be measured on each side using a height adjustable wall goniometer, with videography (i.e. collected using phone) will be used to document shoulder ROM. This is a primary outcome, to examine improvements in mobility of the shoulder.
Timepoint [2] 395502 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [3] 395503 0
Grip Strength
Hand grip strength will be measured via a portable force transducer, by squeezing a hand dynamometer (portable force transducer) as hard as they can. This is a primary outcome measure, to assess changes in the upper limb following treatment.
Timepoint [3] 395503 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [4] 395504 0
Lower Limb Strength
Quadriceps strength will be measured via a portable force transducer, by instructing participants to extend their leg against the force transducer. This is a primary outcome measure, to assess changes in the lower limb following treatment.
Timepoint [4] 395504 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [5] 395505 0
Blood pressure: A standard blood pressure cuff will be placed on the participant’s left upper arm, which will be inflated and then gradually deflated, to measure blood pressure.
Timepoint [5] 395505 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [6] 395542 0
Self-reported Neck Pain – Chronic Pain Grade Scale
Participants will complete the chronic pain grade scale, to acquire information on their neck pain intensity and neck pain-related disability (if any) in the past 6 months.
Timepoint [6] 395542 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [7] 395543 0
Self-reported Current Neck Pain
Participants will be asked to complete the Neck disability Index questionnaire, to determine their neck pain-related disability, at the moment of administration.
Timepoint [7] 395543 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [8] 395544 0
Self-reported Current Neck Pain – Visual Analog Scale
Participants will be asked to complete the neck pain visual analog scale questionnaire, to determine their level of neck pain, at the moment of administration, in the past week and in the past 3 to 6 months.
Timepoint [8] 395544 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [9] 395545 0
Self-reported Upper limb Pain and Dysfunction
Participants will be asked to complete the disabilities of the arm, shoulder and hand (DASH) questionnaire, which will provide information on their upper limb pain and upper limb pain-related disability, if any.
Timepoint [9] 395545 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [10] 395546 0
Self-reported Handedness

Participants will be asked to complete the Edinburgh Handedness Inventory questionnaire, to determine their hand dominance which allow us to understand their grip strength measures.
Timepoint [10] 395546 0
Measure will be assessed at baseline.
Secondary outcome [11] 395547 0
Self-reported Anxiety

Participants will be asked to complete the beck anxiety inventory questionnaire, which will provide information on their current anxiety levels, if any.
Timepoint [11] 395547 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [12] 395548 0
Self-reported Sleep Quality

Participants will be asked to complete the Insomnia Severity Index, which will assess the nature, severity and impact of insomnia.
Timepoint [12] 395548 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [13] 395549 0
Self-reported Body Perception
Participants will be asked to complete the Body Perception Questionnaire Short Form which will provide information regarding their current body perception and autonomic reactivity.
Timepoint [13] 395549 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [14] 395550 0
Self-reported Health Status

Participants will be asked to complete the 36-Item Short Form Health Survey (SF-36), which will provide information regarding their health.
Timepoint [14] 395550 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [15] 395551 0
Self-reported Demographic and Health
Participants will be asked to complete the Demographics and Health Behaviour Questionnaire, which will provide information regarding participants’ health demographic information.
Timepoint [15] 395551 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [16] 395552 0
Self-reported SMI
Participants will be asked to complete the Brain-Body Communication Questionnaire, assessing their central neural processing during various functional/ daily tasks.
Timepoint [16] 395552 0
Measure will be assessed at baseline and at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [17] 395553 0
Recruitment Rate is defined as the number of participants that are recruited per site per a month. Recruitment rate will be calculated as the total number of participants that were recruited and randomized divided by total of number of months spent recruiting participants, at the one site.
Timepoint [17] 395553 0
Measure will be assessed at enrolment completion.
Secondary outcome [18] 395554 0
Retention Rate is defined as the number of recruited and randomized participants who have full sets of valid data for the outcome measures collected. This will be expressed as a percentage, number of participants with complete data sets divided by total number of participants.
Timepoint [18] 395554 0
Measure will be assessed at follow-up (e.g. after the completion of either chiropractic care or a no treatment control period).
Secondary outcome [19] 395555 0
Adverse events in response to the OTZ treatment: A report will be given to the researchers by the chiropractor, which will contain information on the number of participant(s) and what the adverse event was/were.
Timepoint [19] 395555 0
Measure will be assessed during the completion of chiropractic care for the treatment group.
Secondary outcome [20] 395556 0
Compliance to the OTZ treatment: This will be reflected by chiropractor’s report to the researchers. It will contain her notes on the progression of each participant’s improvement following their OTZ treatments.
Timepoint [20] 395556 0
Measure will be assessed during the completion of chiropractic care for the treatment group.
Secondary outcome [21] 395557 0
Acceptability of interventions: This will be assessed qualitatively by asking participants who were allocated to the treatment group about observable changes (i.e. reduced pain, improved mobility, etc.) following the completion of their OTZ treatment at follow-up. We will also ask them about their experience of how acceptable or tolerable the interventions themselves were.
Timepoint [21] 395557 0
Measure will be assessed at follow-up (e.g. after the completion of chiropractic care) for the treatment group.

Eligibility
Key inclusion criteria
Males and females aged 18 – 65 who experience either of the following symptoms and/or problems: recurrent neck problems; decreased shoulder range of motion; difficulty maintaining good posture especially while sitting; unexplained whole-body stiffness that doesn’t benefit from stretching. To be eligible for the study, participants are to have had these issues for at least 3 months and not started any treatments in the past three weeks. These individuals will be screened for the articular dysfunction at the C0-C1 joint complex by the treating chiropractor as this joint dysfunction is the inclusion criterion for the OTZ treatment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with contraindications to chiropractic care such as fractures, tumors, infections, or recent head trauma will be excluded.

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)
Participants will be screened by the treating practitioner for the inclusion and exclusion criteria before enrollment. Once enrolled the allocation into treatment or waitlist control will be performed by the researcher opening a numbered envelope, which has been pre-populated with the participant allocation stated on a piece of paper inside the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be carried out using an Excel Random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Effect size calculations based on data from our feasibility studies indicate that 24 participants per group (48 total) need to be recruited. Given that we are recruiting during COVID with unexpected lockdowns, we will therefore aim to recruit 37 participants per arm to allow for dropouts due to government lockdowns and/or possible Covid exposures where participants are required to self-isolate, e.g. 74 in total.

Data will be statistically analyzed to compare differences in the outcomes for each group between the two time points (e.g. baseline and follow-up - baseline 1 & 2 for the non-treatment group and baseline 1 and post-treatment for the treatment group). Biological sex and age will be analyzed as co-factors to determine if they impact the response to treatment. Feasibility outcomes will include recruitment rate, retention rate, adverse events, compliance, acceptability of interventions) descriptively (mean (SD) for continuous outcomes, frequency (%) for categorical outcomes) with 95% CI, effects sizes for future studies, and narratively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2020
Date of last participant enrolment
Anticipated
Actual
2/05/2021
Date of last data collection
Anticipated
Actual
23/05/2021
Sample size
Target
74
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 22919 0
Canada
State/province [1] 22919 0
Ontario

Funding & Sponsors
Funding source category [1] 306655 0
Charities/Societies/Foundations
Name [1] 306655 0
MITACS
Country [1] 306655 0
Canada
Primary sponsor type
Individual
Name
Bernadette Murphy
Address
Faculty of Health Sciences,
Ontario Tech University
2000 Simcoe St North,
Oshawa, Ontario
L1G 0C5
Country
Canada
Secondary sponsor category [1] 307206 0
Individual
Name [1] 307206 0
Paul Yielder
Address [1] 307206 0
Ontario Tech University
Kinesiology, Faculty of Health Sciences,
2000 Simcoe St North,
Oshawa, Ontario
L1G 0C5
Country [1] 307206 0
Canada
Other collaborator category [1] 281467 0
Individual
Name [1] 281467 0
Heidi Haavik
Address [1] 281467 0
Director of Research
New Zealand College of Chiropractic
6 Harrison Road, Mt Wellington, Auckland, 1060 PO Box 113-044, Newmarket, Auckland, 1149
Country [1] 281467 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306837 0
Ontario Tech Research Ethics Board
Ethics committee address [1] 306837 0
Ethics committee country [1] 306837 0
Canada
Date submitted for ethics approval [1] 306837 0
15/05/2020
Approval date [1] 306837 0
12/08/2020
Ethics approval number [1] 306837 0
15908

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

Contacts
Principal investigator
Name 105186 0
Prof Bernadette Murphy
Address 105186 0
Faculty of Health Sciences
Ontario Tech University
2000 Simcoe St North,
Oshawa, Ontario, L1G 0C5
Canada
Country 105186 0
Canada
Phone 105186 0
+1 905 7218668
Fax 105186 0
Email 105186 0
[email protected]
Contact person for public queries
Name 105187 0
Bernadette Murphy
Address 105187 0
Faculty of Health Sciences
Ontario Tech University
2000 Simcoe St North,
Oshawa, Ontario, L1G 0C5
Canada
Country 105187 0
Canada
Phone 105187 0
+1 905 7218668
Fax 105187 0
Email 105187 0
[email protected]
Contact person for scientific queries
Name 105188 0
Bernadette Murphy
Address 105188 0
Faculty of Health Sciences
Ontario Tech University
2000 Simcoe St North,
Oshawa, Ontario, L1G 0C5
Canada
Country 105188 0
Canada
Phone 105188 0
+1 905 7218668
Fax 105188 0
Email 105188 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.