Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001254785
Ethics application status
Approved
Date submitted
1/11/2013
Date registered
14/11/2013
Date last updated
16/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can osteopathic techniques improve postural control in patients with neck pain?
Scientific title
The effect of cervical spine high-velocity, low amplitude thrust on the postural sway of patients with cervical spine dysfunction
Secondary ID [1] 283486 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonspecific neck pain 290402 0
Condition category
Condition code
Musculoskeletal 290793 290793 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single high velocity, low amplitude thrust, manipulation treatment administered by a registered osteopath to dysfunctional segment(s) of the cervical spine. Procedure comprises a wind up manoeuvre (around 5 s duration) and the thrust (< 1 s duration).

The wash-out period between conditions was 1 week.
Intervention code [1] 288195 0
Rehabilitation
Intervention code [2] 288233 0
Treatment: Other
Comparator / control treatment
Passive, gentle head rotation administered by a registered osteopath. Procedure comprises a wind up manoeuvre (around 5 s duration).
Control group
Placebo

Outcomes
Primary outcome [1] 290787 0
Postural sway assessed by changes in centre of pressure (4 parameters from sway-plate device)
Timepoint [1] 290787 0
Immediately following intervention
Primary outcome [2] 290788 0
Postural sway assessed by changes in centre of pressure (4 parameters from sway-plate device)
Timepoint [2] 290788 0
5 minutes following intervention
Primary outcome [3] 290789 0
Postural sway assessed by changes in centre of pressure (4 parameters from sway-plate device)
Timepoint [3] 290789 0
15 minutes following intervention
Secondary outcome [1] 305287 0
Pain (via 11-point numeric pain scale)
Timepoint [1] 305287 0
Immediately following intervention
Secondary outcome [2] 305288 0
Pain (via 11-point numeric pain scale)
Timepoint [2] 305288 0
5 minutes following intervention
Secondary outcome [3] 305289 0
Pain (via 11-point numeric pain scale)
Timepoint [3] 305289 0
15 minutes following intervention

Eligibility
Key inclusion criteria
Able to read and understand English language
Assessed as having dysfunctional cervical spinal segment (defined as restricted range of motion and tenderness on palpation)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to use of cervical spinal manipulation
Subjective symptoms of vertebrobasilar insufficiency
Signs of vertebrobasilar insufficiency under examination

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)
Foreknowledge of the upcoming allocation to order of treatments was completely prevented by use of a method equivalent to the examples provided (central allocation, sequential numbering of identical containers).

As each participant arrived for their first testing session, internet-based software was used to generate a random number from 1-10. The random production of an odd versus an even number determined their order-of-treatment allocation (rather like tossing a coin). This process occurred subsequently to assessment of their eligibility and enrolment into the study and it was repeated for each participant. It was thus impossible that anyone could have foreseen participant assignment at the time of enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which the participants received the procedures was determined at their enrolment for the study by random number generation of an odd or even number (simple randomisation created by computer software).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants were not told that one condition was designed as a control. Participants faced away from experimenter during measurement of sway to reduce possible body language transmission of expectation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
2-way analysis of variance or non-parametric equivalents.

Prior to the study sample size required to detect change in sway measurements of an effect size of 1.5 (centre of pressure length changes = 20 mm), and with 80% statistical power, was calculated to be 6. Additional participants were recruited to allow for withdrawals from the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2011
Actual
1/08/2011
Date of last participant enrolment
Anticipated
29/02/2012
Actual
16/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
7
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 5547 0
New Zealand
State/province [1] 5547 0
Auckland

Funding & Sponsors
Funding source category [1] 288198 0
University
Name [1] 288198 0
Unitec Institute of Technology
Country [1] 288198 0
New Zealand
Primary sponsor type
University
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] 286953 0
None
Name [1] 286953 0
Address [1] 286953 0
Country [1] 286953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290111 0
Unitec Research Ethics Committee
Ethics committee address [1] 290111 0
Ethics committee country [1] 290111 0
New Zealand
Date submitted for ethics approval [1] 290111 0
08/06/2011
Approval date [1] 290111 0
22/06/2011
Ethics approval number [1] 290111 0
UREC-2011-1188

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

Contacts
Principal investigator
Name 43910 0
Dr Catherine Bacon
Address 43910 0
Department of Osteopathy
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 43910 0
New Zealand
Phone 43910 0
+64 9 815 4302 ext. 5229
Fax 43910 0
Email 43910 0
[email protected]
Contact person for public queries
Name 43911 0
Alison Fisher
Address 43911 0
Sutherland Osteopathy
Shop 4/7-19 East Parade
Sutherland
New South Wales 2232
Country 43911 0
Australia
Phone 43911 0
+61 2 9545 2228
Fax 43911 0
Email 43911 0
[email protected]
Contact person for scientific queries
Name 43912 0
Catherine Bacon
Address 43912 0
Department of Osteopathy
Unitec Institute of Technology
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country 43912 0
New Zealand
Phone 43912 0
+64 9 815 4302 ext. 5229
Fax 43912 0
Email 43912 0
[email protected]

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.