Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000627459
Ethics application status
Approved
Date submitted
10/04/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasiblity study evaluating the effect of One to Zero (OTZ) chiropractic technique on brain functionand health in adults with neck dysfunction
Scientific title
The effect of atlantooccipital joint dysfunction and its treatment on proprioception, motor control and health related quality of life: a repeated measures study in adults with neck dysfunction
Secondary ID [1] 314180 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study describes feasibility studies that informed record ACTRN12621001191886

Health condition
Health condition(s) or problem(s) studied:
Neck dysfunction 337033 0
Sensorimotor dysfunction 337034 0
Impaired health and well-being 337035 0
Impaired mobility 337036 0
Atlantooccipital joint dysfunction 337037 0
Impaired head and neck proprioception 337038 0
Autonomic dysfunction 337039 0
Condition category
Condition code
Musculoskeletal 333484 333484 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 showed 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 provided the treatment. The OTZ treatment was 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 received chiropractic care with the OTZ treatment for a total of 4 to 6visits (2 to 3 visits a week for an average of 2 to 3 weeks), dependent on the severity and chronicity of eachparticipant’s joint dysfunction(s). The number of required visits for each participant was decided by thechiropractor providing the treatment, who will use their clinical judgement to make this decision. Each treatment session was 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 assessmentof C0 – C1 joint complex and areas of cervicothoracic spinal dysfunction. The OTZ treatment was performed at the chiropractic clinic where the registered chiropractor administering the treatment practices. In order to monitor adherence to the intervention, the chiropractor provided the researchers with a list of participants and number of treatment sessions that were attended over the intervention period.
Intervention code [1] 330779 0
Rehabilitation
Intervention code [2] 330780 0
Treatment: Other
Comparator / control treatment
This is a repeated measures design where each participant acted as their own control. They experienced a 2 to 3 week wait period where no new treatments were allowed in the wait period, followed by 2 to 3 weeks of treatment.
Control group
Active

Outcomes
Primary outcome [1] 341063 0
Neuromuscular function of Neck Muscles
Timepoint [1] 341063 0
Measure was assessed at baseline and at follow-up (e.g. after the completion of the 2 to 3 week no treatment control period and then after the 2 to 3 weeks of chiropractic care
Primary outcome [2] 341064 0
Head repositioning accuracy
Timepoint [2] 341064 0
Measure will be assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Primary outcome [3] 341065 0
Physiological outcome measure
Timepoint [3] 341065 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Secondary outcome [1] 446000 0
Neck Range of Motion (ROM)
Timepoint [1] 446000 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [2] 446001 0
Shoulder ROM
Timepoint [2] 446001 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [3] 446002 0
Grip Strength
Timepoint [3] 446002 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [4] 446003 0
Lower Limb Strength
Timepoint [4] 446003 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [5] 446004 0
Self-reported current neck pain
Timepoint [5] 446004 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Secondary outcome [6] 446005 0
Self-reported Current Neck Pain – Visual Analog Scale
Timepoint [6] 446005 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [7] 446006 0
Self-reported Upper limb Pain and Dysfunction
Timepoint [7] 446006 0
Measure was assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of chiropractic care (2 to 3 weeks).
Secondary outcome [8] 446011 0
Self-reported Anxiety
Timepoint [8] 446011 0
Measure will be assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Secondary outcome [9] 446015 0
Self-reported Sleep Quality
Timepoint [9] 446015 0
Measure will be assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Secondary outcome [10] 446016 0
Self-reported Health Status
Timepoint [10] 446016 0
Measure will be assessed at baseline, after the no treatment control period (2 to 3 weeks) and completion of either chiropractic care (2 to 3 weeks).
Secondary outcome [11] 446019 0
Adverse events in response to the OTZ treatment:
Timepoint [11] 446019 0
Measure assessed following the completion of chiropractic care for the treatment group.

Eligibility
Key inclusion criteria
Males and females aged 18 – 65 who experience any 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 benefi t from stretching. To be eligible for the study, participants are to have had these issues for at least 3 months and not started anytreatments in the past three weeks. These individuals were screened for the articular dysfunction at the C0-C1 joint complex by the treating chiropractor as this joint dysfunction is the inclusion criterion for theOTZ 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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Repeated measures ANOVA with partial eta squared to determine effect size for future RCTs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/06/2018
Date of last participant enrolment
Anticipated
Actual
1/04/2019
Date of last data collection
Anticipated
Actual
27/05/2019
Sample size
Target
22
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 26959 0
Canada
State/province [1] 26959 0
Ontario

Funding & Sponsors
Funding source category [1] 318696 0
Government body
Name [1] 318696 0
Mathematics of Information Technology and Complex Systems (MITACS)
Country [1] 318696 0
Canada
Primary sponsor type
Individual
Name
Bernadette Murphy-Ontario Tech University
Address
Country
Canada
Secondary sponsor category [1] 321125 0
Individual
Name [1] 321125 0
Paul Yielder-Ontario Tech University
Address [1] 321125 0
Country [1] 321125 0
Canada
Secondary sponsor category [2] 321126 0
Individual
Name [2] 321126 0
Heidi Haavik-New Zealand College of Chiropractic
Address [2] 321126 0
Country [2] 321126 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317305 0
Ontario Tech University Research Ethics Board
Ethics committee address [1] 317305 0
Ethics committee country [1] 317305 0
Canada
Date submitted for ethics approval [1] 317305 0
04/04/2018
Approval date [1] 317305 0
07/06/2018
Ethics approval number [1] 317305 0
14817

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

Contacts
Principal investigator
Name 140634 0
Prof Bernadette Murphy
Address 140634 0
Faculty of Health Sciences Ontario Tech University 2000 Simcoe St North, Oshawa, Ontario, L1G 0C5Canada
Country 140634 0
Canada
Phone 140634 0
+1 905 7218668
Fax 140634 0
Email 140634 0
[email protected]
Contact person for public queries
Name 140635 0
Bernadette Murphy
Address 140635 0
Faculty of Health Sciences Ontario Tech University 2000 Simcoe St North, Oshawa, Ontario, L1G 0C5Canada
Country 140635 0
Canada
Phone 140635 0
+1 905 7218668
Fax 140635 0
Email 140635 0
[email protected]
Contact person for scientific queries
Name 140636 0
Bernadette Murphy
Address 140636 0
Faculty of Health Sciences Ontario Tech University 2000 Simcoe St North, Oshawa, Ontario, L1G 0C5Canada
Country 140636 0
Canada
Phone 140636 0
+1 905 7218668
Fax 140636 0
Email 140636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: as this was a feasibility study, we did not request permssion for this at the time of the original ethics application.



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.