Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000470291
Ethics application status
Approved
Date submitted
4/06/2009
Date registered
16/06/2009
Date last updated
16/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined dry-needling, advice and exercise: a randomized controlled trial in chronic whiplash
Scientific title
In people with chronic whiplash is combined dry-needling, advice and exercise more effective than combined sham dry-needling, advice and exercise on pain and disability levels
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic whiplash associated disorders 236926 0
Condition category
Condition code
Musculoskeletal 237286 237286 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dry-needling, advice and exercise:

Participants receive a copy of the educational booklet ‘Whiplash injury recovery: a self management guide’ published by the Motor Accident Insurance Commision, Queensland (MAIC). This booklet will be issued on completion of the initial assessment session at the Whiplash Laboratory and inclusion in the trial.

The intervention is a 6 week programme which includes 6 x 30 minute treatments of dry-needling and exercise delivered in the first 3 weeks, followed by 4 exercise only sessions in the following 3 weeks.

Dry needling involves tapping a very fine filament needle into senstive muscle areas identified by the physiotherapist. The muscles that mat be treated include the posterior muscles of the neck and shoulder girdle region.

The exercise component will comprise of specific exercises to improve range of neck movement, muscle control of the neck flexors and extensors and postural control of the neck and shoulder girdles. All exercises will be low load and sub-maximal in nature and are designed to be pain-free. Participants will attend the physiotherpist for education of this exercise programme and they are encouraged to carry-out their home exercise programme 2-3 x a day, each session lasting 10 minutes. The postural corrections and similar components of the programme should be incorporated in the participants' every day activities. The participant is encouraged to continue their exercise programme and self manage on completion of the 6 week programme.
Intervention code [1] 236717 0
Rehabilitation
Comparator / control treatment
Sham dry-needling, advice and exercise:

Participants receive a copy of the educational booklet ‘Whiplash injury recovery: a self management guide’ published by MAIC. This booklet will be issued on completion of the initial assessment session at the Whiplash Laboratory and inclusion in the trial.

The intervention is a 6 week programme which includes 6 x 30 minute treatments of sham dry-needling and exercise delivered in the first 3 weeks, followed by 4 exercise only sessions in the following 3 weeks.

Sham dry-needling uses a blunt needle that does not penetrate the skin. The procedure for identifying sensitive muscle areas of the neck and shoulder girdles will the same as for the intervention.

The exercise component is identical to the exercise programme delivered to the dry-needling programme. The exercise component will comprise of specific exercises to improve range of neck movement, muscle control of the neck flexors and extensors and postural control of the neck and shoulder girdles. All exercises will be low load and sub-maximal in nature and are designed to be pain-free. Participants will attend the physiotherpist for education of this exercise programme and they are encouraged to carry-out their home exercise programme 2-3 x a day, each session lasting 10 minutes. The postural corrections and similar components of the programme should be incorporated in the participants' every day activities. The participant is encouraged to continue their exercise programme and self manage on completion of the 6 week programme.
Control group
Placebo

Outcomes
Primary outcome [1] 238097 0
Neck Disability Index (NDI): a neck specific measure of pain and disability
Timepoint [1] 238097 0
6, 12, 24 and 52 weeks after randomisation
Secondary outcome [1] 242301 0
Average pain intensity over last week (0-10 scale)
Timepoint [1] 242301 0
6, 12, 24 and 52 weeks after randomisation

Eligibility
Key inclusion criteria
Whiplash associated disorder Grade II of at least 3 months duration but less than 12 months duration.

Whiplash causes at least moderate pain and disability with scores of greater or equal to 28/100 on the Neck Disability Index (NDI).

The presence of sensory hypersensitivity, defined as the presence of 2 out of a possible 3 of the following: cold pain threshold (> 15 degrees celcius, males and females); pressure pain thresholds over the cervical spine (females < 185 kPa. Males < 210 kPa); pressure pain thresholds over the median nerve (females < 210 kPa. Males < 250 kPa)

Not currently receiving care for whiplash.

Participants should be naïve to the use of dry needling in the treatment of musculoskeletal pain.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine).

Confirmed fracture or dislocation at time of injury.

Nerve root compromise (at least 2 of the following signs: weakness/reflex changes/sensory loss, associated with the same spinal nerve).

Spinal surgery in the past 12 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237108 0
Government body
Name [1] 237108 0
National Health and Medical Research Council (NHMRC)
Country [1] 237108 0
Australia
Primary sponsor type
Individual
Name
A/Prof Michele Sterling
Address
Centre of National Research on Disability and Rehabilitation Medicine (CONROD), University of Qld
Level 3Mayne Medical School
Herston Road
Herston
QLD 4006
Country
Australia
Secondary sponsor category [1] 4608 0
Individual
Name [1] 4608 0
Prof Bill Vicenzino
Address [1] 4608 0
Centre of Clinical Research Excellence (CCRE): Spine
Division of Physiotherapy
Room 505, Level 5
Therapies Building 84a
The University of Queensland
Services Road
St Lucia
Brisbane
QLD 4072
Country [1] 4608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239206 0
University of Queensland (UQ) Medical Research Ehtics Committee
Ethics committee address [1] 239206 0
Ethics committee country [1] 239206 0
Australia
Date submitted for ethics approval [1] 239206 0
Approval date [1] 239206 0
04/02/2009
Ethics approval number [1] 239206 0

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

Contacts
Principal investigator
Name 29706 0
Address 29706 0
Country 29706 0
Phone 29706 0
Fax 29706 0
Email 29706 0
Contact person for public queries
Name 12953 0
A/Prof Michele Sterling
Address 12953 0
CONROD, University of Qld
Level 3, Mayne Medical School
Herston Road
Herston
QLD 4006
Country 12953 0
Australia
Phone 12953 0
61 7 33655344
Fax 12953 0
Email 12953 0
[email protected]
Contact person for scientific queries
Name 3881 0
A/Prof Michele Sterling
Address 3881 0
CONROD, University of Qld
Level 3, Mayne Medical School
Herston Road
Herston
QLD 4006
Country 3881 0
Australia
Phone 3881 0
61 7 33655344
Fax 3881 0
Email 3881 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
SourceTitleYear of PublicationDOI
EmbaseDry-needling and exercise for chronic whiplash-Associated disorders: A randomized single-blind placebo-controlled trial.2015https://dx.doi.org/10.1097/01.j.pain.0000460359.40116.c1
Dimensions AICervical facet joint nociception modulates physical and psychological features of chronic whiplash2015https://doi.org/10.1016/j.physio.2015.03.1400
N.B. These documents automatically identified may not have been verified by the study sponsor.