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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
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
Secondary ID [1] 283544 0
Nil known
Universal Trial Number (UTN)
U1111-1141-5779
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic neck pain 288795 0
Condition category
Condition code
Musculoskeletal 289152 289152 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297010 297010 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286894 0
Rehabilitation
Intervention code [2] 286895 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 289262 0
Neck Disability Index
Timepoint [1] 289262 0
3 weeks
Primary outcome [2] 289263 0
Patient-Specific Function Scale
Timepoint [2] 289263 0
3 weeks
Primary outcome [3] 289264 0
McGill Pain Questionnaire
Timepoint [3] 289264 0
3 weeks
Secondary outcome [1] 302121 0
Visual Analogue Scale for degree of neck pain
Timepoint [1] 302121 0
6 weeks (uncontrolled - whole cohort)
Secondary outcome [2] 302122 0
Neck Disability Index
Timepoint [2] 302122 0
6 weeks (uncontrolled - whole cohort)
Secondary outcome [3] 302123 0
Patient-Specific Functional Scale
Timepoint [3] 302123 0
6 weeks (uncontrolled - whole cohort)
Secondary outcome [4] 302124 0
McGill Pain Questionnaire - Pain Rating Index
Timepoint [4] 302124 0
6 weeks (uncontrolled - whole cohort)
Secondary outcome [5] 302125 0
McGill Pain Questionnaire - Present Pain Index
Timepoint [5] 302125 0
6 weeks (uncontrolled - whole cohort)

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
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
15/09/2011
Date of last participant enrolment
Anticipated
17/02/2012
Actual
3/04/2012
Date of last data collection
Anticipated
Actual
22/05/2012
Sample size
Target
24
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 4988 0
New Zealand
State/province [1] 4988 0
Auckland

Funding & Sponsors
Funding source category [1] 287036 0
Other
Name [1] 287036 0
Unitec Institute of Technology
Country [1] 287036 0
New Zealand
Primary sponsor type
Other
Name
Unitec Institute of Technology
Address
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 285814 0
None
Name [1] 285814 0
Address [1] 285814 0
Country [1] 285814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289070 0
Unitec Research Ethics Committee
Ethics committee address [1] 289070 0
Ethics committee country [1] 289070 0
New Zealand
Date submitted for ethics approval [1] 289070 0
06/07/2011
Approval date [1] 289070 0
28/07/2011
Ethics approval number [1] 289070 0
2011-1196

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

Contacts
Principal investigator
Name 39070 0
Dr Catherine Bacon
Address 39070 0
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 39070 0
New Zealand
Phone 39070 0
+64 9 849 4180 x8407
Fax 39070 0
Email 39070 0
cbacon@unitec.ac.nz
Contact person for public queries
Name 39071 0
Monique Gasson
Address 39071 0
Premier Osteo and Physio
Unit 2, 1 View Rd
Glenfield
Auckland 0627
Country 39071 0
New Zealand
Phone 39071 0
+64 9 444 3231
Fax 39071 0
Email 39071 0
monique.gasson.nz@gmail.com
Contact person for scientific queries
Name 39072 0
Catherine Bacon
Address 39072 0
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 39072 0
New Zealand
Phone 39072 0
+64 9 849 4180 x8407
Fax 39072 0
Email 39072 0
cbacon@unitec.ac.nz

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.