Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000073909
Ethics application status
Approved
Date submitted
19/07/2010
Date registered
19/01/2011
Date last updated
19/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of physiotherapy on patients with dizziness and pain caused by a neck problem
Scientific title
The identification and treatment with manual therapy of patients with cervicogenic dizziness and pain
Secondary ID [1] 253138 0
Nil
Universal Trial Number (UTN)
U1111-1113-7748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dizziness and pain from cervical spine problems 257248 0
Condition category
Condition code
Musculoskeletal 257388 257388 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to cervical Sustained Natural Apophyseal Glides (SNAGs) as described by Brian Mulligan, passive joint mobilisation as described by Geoff Maitland or placebo groups. AThe first group of participants will receive SNAGS as described by Brian Mulligan (Mulligan, 2004). The participant, in the sitting position, is asked to move his head in the direction that produces their symptoms. The participant is to stop if any dizziness is reproduced. During the application of the mobilization, the participant should stay symptom-free. As the patient moves their head the physiotherapist gently glides the C1 or C2 vertebra and sustains the glide through the movement. passive joint mobilisation or Maitland mobilisation is where the therapist uses his thumbs to rhythmically apply pressure to a vertebra. Participants will receive two to six treatments (15 -45 mins) by an experienced physiotherapist over three to six weeks at the discretion of the treating therapist.
Intervention code [1] 256369 0
Treatment: Other
Comparator / control treatment
The placebo group will receive an intervention with a detuned machine. This is a laser machine which has been deactivated by the manufacturer. The laser is commonly used by physiotherapists to treat musculo-skeletal symptoms (Reid et al, 2008). The laser will appear to operate normally to the participant, with a light and beeping sound, but will not produce any effective emission. The detuned laser, which has been shown to have a very strong placebo effect (Irnich, Behrens, Molzen, Konig, Glegitsch, Krauss, Natalis, Senn, Beyer & Schops, 2001) will be given for 2 minutes on a site in the neck, without touching the skin. This duration is consistent with normal laser application in standard physiotherapy practise.
Control group
Placebo

Outcomes
Primary outcome [1] 258308 0
Severity of dizziness (an average level over the
previous few days) will be measured with a 10 cm horizontal visual analogue scale (VAS) ranging from 'no dizziness' to 'the worst dizziness imaginable'.
Timepoint [1] 258308 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Primary outcome [2] 258309 0
The Chattecx Balance Machine or posturography will be used to measure and quantify disturbances in balance.
Timepoint [2] 258309 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Primary outcome [3] 259700 0
Disability caused by dizziness will be measured with the Dizziness Handicap Inventory (DHI)
Timepoint [3] 259700 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [1] 264011 0
Global perceived effect (GPE) will be measured by self-assessment on a six-point scale
Timepoint [1] 264011 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [2] 266406 0
Severity of cervical pain and headache (an average level over the
previous few days) will be measured with a 10 cm horizontal visual
analogue scale (VAS) ranging from ?no pain to ?the worst Pain imaginable?
Timepoint [2] 266406 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [3] 266407 0
Frequency of dizziness will be measured on a six-point rating scale
Timepoint [3] 266407 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [4] 266408 0
Participants will be given a diary and asked to log medication use, visits to the doctor, visits to other health professionals, time off work, change in social engagements and adherence to home exercises.
Timepoint [4] 266408 0
The diary will be kept througout the length of the study
Secondary outcome [5] 266409 0
Balance will also be measured with the PhysioLog balance system which is a balance assessment tool capable of quantifying balance.
Timepoint [5] 266409 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [6] 266410 0
Neck range of motion will be measured with a CROM (cervical range of motion) device.
Timepoint [6] 266410 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed.
Secondary outcome [7] 266411 0
Neck repositioning sense will be assessed with the CROM. This task tests the participants ability to actively reposition their head and neck. The participant will be blindfolded and seated with the head in a neutral position. He will be asked to move his head into either rotation or extension.
Timepoint [7] 266411 0
Follow up measurements will be performed at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after treatment is completed

Eligibility
Key inclusion criteria
Inclusion criteria:
- 18-90 years old
- has dizziness described as imbalance related to neck movements or positions and/or with a stiff and/or painful neck
- has had the symptoms greater than three months
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
The participant should be free of any known conditions that would put them at risk of injury:
- a history of inflammatory joint disease
- spinal cord pathology
- cervical spine infection
- bony disease or marked osteoporosis
- marked cervical spine disc protrusion
- cervical spine cancer
- acute nerve root symptoms (severe pain, weakness, pins and needles or numbness in the arm or hand for less than 6 weeks)
- recent fracture/dislocation of the neck (in the last 3 months)
- previous surgery to the upper cervical spine
Participants will also be excluded if they have other compounding factors:
- physiotherapy or similar treatment to the neck in the previous month
- pregnancy
- compensable cases
- inability to speak or read English

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)
A neurologist screens the participants to see if they are suitable to have treatment in the study. He is unaware what group they will go into.
Randomization will be done by an independent "off-site'' statistician using randomisation by computer and treatments will be allocated to patients by the researcher choosing the next available sealed opaque envelope with the computer generated random allocation to treatment group number inside. Randomization: generation
Participants will be randomly allocated to the Mulligan SNAG group, the Maitland mobilization group or the placebo group using a randomized block design. Randomization will be done by an independent statistician and treatments will be allocated to patients by the researcher choosing the next available sealed opaque envelope with the computer generated random allocation to treatment group inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician used computer generated random allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
An economic evaluation by a health economist will be performed.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256878 0
Other Collaborative groups
Name [1] 256878 0
Mulligan Concept Teachers Association
Country [1] 256878 0
New Zealand
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, 2308
NSW
Country
Australia
Secondary sponsor category [1] 257514 0
None
Name [1] 257514 0
Address [1] 257514 0
Country [1] 257514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258884 0
Human Research Ethics Committee, The University of Newcastle
Ethics committee address [1] 258884 0
The Universiity of Newcastle
University Drive
Callaghan. 2308, NSW
Ethics committee country [1] 258884 0
Australia
Date submitted for ethics approval [1] 258884 0
Approval date [1] 258884 0
24/03/2010
Ethics approval number [1] 258884 0
H2009-0377

Summary
Brief summary
The aim of this study is to conduct a randomised controlled trial to compare two forms of manual therapy against each other and to a placebo in reducing symptoms of cervicogenic dizziness (imbalance and neck pain) in the longer term. Although these are standard treatments in physiotherapy practice they have not been fully evaluated. Outcome measures will be five self-report questionnaires, keeping a diary and measurements of neck range-of-motion, head repositioning and balance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31100 0
Address 31100 0
Country 31100 0
Phone 31100 0
Fax 31100 0
Email 31100 0
Contact person for public queries
Name 14347 0
Sue Reid
Address 14347 0
School of Physiotherapy
Faculty of Health
University of Newcastle
University Drive
Callaghan 2308 NSW
Country 14347 0
Australia
Phone 14347 0
+61 2 49215925
Fax 14347 0
Email 14347 0
[email protected]
Contact person for scientific queries
Name 5275 0
Sue Reid
Address 5275 0
School of Physiotherapy
Faculty of Health
University of Newcastle
University Dr
Callaghan 2308 NSW
Country 5275 0
Australia
Phone 5275 0
+61 2 49215925
Fax 5275 0
Email 5275 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
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