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Trial registered on ANZCTR


Trial ID
ACTRN12613000653763
Ethics application status
Not yet submitted
Date submitted
5/06/2013
Date registered
13/06/2013
Date last updated
13/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of chiropractic neck manipulation for improvement of neck pain, postural and dynamic balance, and cognition in the elderly: A feasibility study
Scientific title
Efficacy of chiropractic neck manipulation compared to sham manipulation in decreasing scores on the Dizziness Handicap Inventory, Neck Disability Index and other measures of balance and cognition in the community dwelling elderly
Secondary ID [1] 282625 0
None
Universal Trial Number (UTN)
U1111-1144-0406
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific dizziness 289316 0
Chronic neck pain 289317 0
Geriatric falls 289318 0
Condition category
Condition code
Musculoskeletal 289654 289654 0 0
Other muscular and skeletal disorders
Neurological 289655 289655 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 289656 289656 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chiropractic manipulation of the neck will be administered to the experimental group with or without massage. Chiropractic manipulation will consist of gentle application of manual high velocity low amplitude thrust procedures commonly practised by chiropractors. Treatment will be delivered twice a week over a period of 8 weeks. All treatment sessions will take 30 minutes each. The decision to include or exclude massage will depend on the clinical judgement of the treating investigator in determining whether hypertonicity exists in the muscles of the neck.
Intervention code [1] 287291 0
Treatment: Other
Comparator / control treatment
The control group will be administered a sham manipulation procedure known as the Outcomes of Usual Chiropractic, Harm & Efficacy (OUCH) protocol as previously published (1). Briefly, this will involve the application of the practitioners hands to the participants neck as well as detuned ultrasound and the "sham" thrust of an Activator TM instrument set at zero. These treatments will be given twice a week over a period of eight weeks. Each sham treatment session will take 30 minutes.

Reference:
(1) Walker BF, Losco B, Clarke BR, Hebert J, French S, Stomski NJ. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial. Trials. 2011;12:235.
Control group
Placebo

Outcomes
Primary outcome [1] 289733 0
Dizziness Handicap Inventory (DHI)
Timepoint [1] 289733 0
One week following the completion of treatment regime.
Secondary outcome [1] 303128 0
Visual Analogue Scale for dizziness
Timepoint [1] 303128 0
One week following the completion of the treatment phase
Secondary outcome [2] 303129 0
Neck Disability Index for neck pain
Timepoint [2] 303129 0
One week following the completion of the treatment phase
Secondary outcome [3] 303130 0
Falls Efficacy Scale International for fear of falling
Timepoint [3] 303130 0
One week following the completion of the treatment phase
Secondary outcome [4] 303131 0
Visual Analogue Scale for neck pain
Timepoint [4] 303131 0
One week following the completion of the treatment phase
Secondary outcome [5] 303132 0
Visual Analogue Scale for low back pain
Timepoint [5] 303132 0
One week following the completion of the treatment phase
Secondary outcome [6] 303133 0
Oswestry Disability Index for low back pain
Timepoint [6] 303133 0
One week following the completion of the treatment phase
Secondary outcome [7] 303134 0
Visual Analogue Scale for tinnitus
Timepoint [7] 303134 0
One week following the completion of the treatment phase
Secondary outcome [8] 303135 0
Centre of Pressure changes using a forceplate
Timepoint [8] 303135 0
One week following the completion of the treatment phase
Secondary outcome [9] 303136 0
Range of Motion using a digital goniometer
Timepoint [9] 303136 0
One week following the completion of the treatment phase
Secondary outcome [10] 303137 0
Tenderness over the cervical spine using a pressure algometer
Timepoint [10] 303137 0
One week following the completion of the treatment phase
Secondary outcome [11] 303138 0
Montreal Cognitive Assessment and Stroop Tests for cognitive function
Timepoint [11] 303138 0
One week following the completion of the treatment phase
Secondary outcome [12] 303139 0
Quality of Life as measured by the RAND-36 questionnaire
Timepoint [12] 303139 0
One week following the completion of the treatment phase
Secondary outcome [13] 303140 0
Satisfaction with treatment using a five point scale.
Timepoint [13] 303140 0
One week following the completion of the treatment phase

Eligibility
Key inclusion criteria
Neck pain and concommitant dizziness or unsteadiness of three months duration or longer, whether constant or intermittent.
Minimum age
65 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed vestibular pathology such as Meniere's disease or benign paroxysmal positional vertigo (BPPV); history or cerebrovascular accident or myocardial infarct; psychiatric disease; active inflammatory spondyloarthropathies; recent spinal trauma; osteomyelitis; spinal tumours; acute myelopathy; those who have had neck spinal manipulative therapy or neck massage in the last three months.

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)
Group allocations will be concealed from the investigators by placing them in opaque consecutively numbers sealed envelopes. As participants become eligible for the study, envelopes will be opened by a research assistant not involved in the conduct of baseline or outcome measurements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects will be randomly assigned at the baseline appointment by using a permuted block randomisation protocol to one of two groups (n=20). The randomization schedule will be done by the study statistician before recruitment using a computer generated random list of numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data analysis will be performed using SPSS software for Windows (version 20). Results are expressed as mean (95% confidence intervals) or median (range) where appropriate. Student's t-test and chi-squared analysis will be used to compare continuous and categorical variables, respectively. Factors effecting final DHI scores will be evaluated with ANCOVA. Participant's age and baseline values for the corresponding dependent varibles will serve as co-variates in these analyses. Since this is a feasibility study a sample size calculation is unnecessary. This study will act as a pilot for the larger RCT planned for a subsequent stage where 44 subjects will be needed per group for 90% power in detecting a 20% change in the primary outcome measure (DHI), also factoring in a 30% rate of drop-out.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287403 0
University
Name [1] 287403 0
RMIT University
Address [1] 287403 0
School of Health Sciences, RMIT University, Plenty Road, Bundoora VIC 3083 Australia
Country [1] 287403 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Azari
Address
Office 26A, Level 5, Building 201, School of Health Sciences, RMIT University, Plenty Road, Bundoora VIC 3083 Australia
Country
Australia
Secondary sponsor category [1] 286142 0
None
Name [1] 286142 0
Address [1] 286142 0
Country [1] 286142 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289379 0
Human Research Ethics Committee
Ethics committee address [1] 289379 0
RMIT University Research and Innovation, City Campus
GPO Box 2476 Melbourne 3001 VIC Australia
Ethics committee country [1] 289379 0
Australia
Date submitted for ethics approval [1] 289379 0
04/05/2012
Approval date [1] 289379 0
Ethics approval number [1] 289379 0
HREC 29/13

Summary
Brief summary
The primary focus of this study is dizziness in the community dwelling elderly. Neck pain and dysfunction can cause dizziness and may be an important under-investigated risk factor for falls in the elderly. Neck manipulation is known to be effective for neck pain. There is also preliminary evidence that physical treatments administered to the neck (including manipulation) may improve dizziness. This study will use clinical rigorous research methods to determine whether chiropractic manipulation can be used to successfully treat dizziness, thereby lowering the likelihood of falls in the elderly. Falls in the elderly are a significant public health problem in need of new and innovative management strategies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40546 0
Dr Michael Azari
Address 40546 0
Office 26A, Level 5, Building 201, RMIT University, Plenty Road, Bundoora VIC, 3083
Country 40546 0
Australia
Phone 40546 0
+61 3 99257744
Fax 40546 0
Email 40546 0
michael.azari@rmit.edu.au
Contact person for public queries
Name 40547 0
Dr Michael Azari
Address 40547 0
Office 26A, Level 5, Building 201, RMIT University, Plenty Road, Bundoora VIC, 3083
Country 40547 0
Australia
Phone 40547 0
+61 3 99257744
Fax 40547 0
Email 40547 0
michael.azari@rmit.edu.au
Contact person for scientific queries
Name 40548 0
Dr Michael Azari
Address 40548 0
Office 26A, Level 5, Building 201, RMIT University, Plenty Road, Bundoora VIC, 3083
Country 40548 0
Australia
Phone 40548 0
+61 3 99257744
Fax 40548 0
Email 40548 0
michael.azari@rmit.edu.au