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Trial registered on ANZCTR
Registration number
ACTRN12613001267741
Ethics application status
Approved
Date submitted
8/11/2013
Date registered
18/11/2013
Date last updated
23/02/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of osteopathic therapy on chronic neck pain and disability: associations with neck posture and mobility
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Scientific title
The effect of osteopathic treatment on neck pain and disability in adults with non-specific chronic neck pain and associations with neck posture and mobility
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Secondary ID [1]
283544
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Nil known
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Universal Trial Number (UTN)
U1111-1141-5779
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic neck pain
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Condition category
Condition code
Musculoskeletal
289152
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
297010
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Semi-structured 30 minute osteopathy treatment, administered 2 times per week for 3 weeks by supervised, final year osteopathy students. Treatment consisted of a selection of manual techniques applied to the neck and upper-mid back and included postural advice and exercise prescription if indicated.
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Intervention code [1]
286894
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Rehabilitation
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
Participants were randomised to immediate or 3-week delayed start of treatment. The group randomised to delayed start acted as a control group for the period of the delay.
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Control group
Active
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Outcomes
Primary outcome [1]
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Neck Disability Index
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Assessment method [1]
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Timepoint [1]
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3 weeks
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Primary outcome [2]
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Patient-Specific Function Scale
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Assessment method [2]
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Timepoint [2]
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3 weeks
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Primary outcome [3]
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McGill Pain Questionnaire
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Assessment method [3]
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Timepoint [3]
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3 weeks
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Secondary outcome [1]
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Visual Analogue Scale for degree of neck pain
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Assessment method [1]
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Timepoint [1]
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6 weeks (uncontrolled - whole cohort)
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Secondary outcome [2]
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Neck Disability Index
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Assessment method [2]
302122
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Timepoint [2]
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6 weeks (uncontrolled - whole cohort)
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Secondary outcome [3]
302123
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Patient-Specific Functional Scale
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Assessment method [3]
302123
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Timepoint [3]
302123
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6 weeks (uncontrolled - whole cohort)
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Secondary outcome [4]
302124
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McGill Pain Questionnaire - Pain Rating Index
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Assessment method [4]
302124
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Timepoint [4]
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6 weeks (uncontrolled - whole cohort)
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Secondary outcome [5]
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McGill Pain Questionnaire - Present Pain Index
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Assessment method [5]
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Timepoint [5]
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6 weeks (uncontrolled - whole cohort)
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Eligibility
Key inclusion criteria
Aged 25 - 65 years
Current neck pain of >=12 weeks duration
Pain intensity at least 3/10 at some point on most days
Primary complaint perceived as arising from the neck region (defined)
Able to understand English language
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Minimum age
25
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Signs of spinal pathology
Signs of nerve root compression
Recent (previous 6 months) history of spinal surgery or whiplash
History of symptoms related to significant trauma
Previous substantial experience of osteopathy treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed. The randomised allocation for immediate versus delayed-start was produced at the start of the trial and was available to those assessing participants for eligibility.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Single block randomisation schedule generated prior to enrollment using an Internet-based computer programme (www.randomization.com) set for the target number of participants.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Participants were randomly assigned to 3-week delayed start of treatment, thus creating a randomised controlled trial for first 3 weeks of treatment. All participants eventually received 3 weeks of treatment and 3-week post-treatment follow-up. Secondary analysis of whole cohort was performed.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Mixed ANOVA model (1 repeated-measures factor and 1 independent-measures factor) for RCT analysis.
Mixed-model (multi-level linear) approach to ANOVA for single cohort analysis.
Prior to the study, calculations showed that a sample size of 10 participants per group would be required to detect a change in NDI or VAS of an effect size of 1 (VAS changes = 2.7) assuming 80% statistical power and alpha = 5%. An additional 2 participants per group was targeted to allow for possible withdrawals from the study.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2011
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Actual
15/09/2011
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Date of last participant enrolment
Anticipated
17/02/2012
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Actual
3/04/2012
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Date of last data collection
Anticipated
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Actual
22/05/2012
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Sample size
Target
24
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Accrual to date
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Final
28
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Unitec Institute of Technology
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Address [1]
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Carrington Rd, Mt Albert
Private Bag 92025
Vitoria Street West
Auckland 1142
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Country [1]
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New Zealand
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Primary sponsor type
Other
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Name
Unitec Institute of Technology
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Address
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
285814
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Unitec Research Ethics Committee
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Ethics committee address [1]
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Research Office and Postgraduate Centre
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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06/07/2011
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Approval date [1]
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28/07/2011
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Ethics approval number [1]
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2011-1196
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Summary
Brief summary
To establish the effectiveness of osteopathic treatment as it is currently practised in New Zealand on neck pain and disability. A secondary aim was determine whether neck posture and mobility were associated with the effect.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Catherine Bacon
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Address
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Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 849 4180 x8407
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Monique Gasson
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Address
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Premier Osteo and Physio
Unit 2, 1 View Rd
Glenfield
Auckland 0627
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Country
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New Zealand
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Phone
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+64 9 444 3231
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Catherine Bacon
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Address
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Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
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Country
39072
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New Zealand
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Phone
39072
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+64 9 849 4180 x8407
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Fax
39072
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Email
39072
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[email protected]
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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.
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