Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000614998
Ethics application status
Not yet submitted
Date submitted
12/06/2011
Date registered
15/06/2011
Date last updated
15/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does acupuncture/dry needling applied as a sensory discrimination training tool decrease pain in chronic low back pain patients more than acupuncture alone?
Scientific title
Does acupuncture/dry needling applied as a sensory discrimination training tool decrease pain in chronic low back pain patients more than acupuncture alone?
Secondary ID [1] 262355 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic nonspecific lower back pain 268056 0
Condition category
Condition code
Physical Medicine / Rehabilitation 268198 268198 0 0
Physiotherapy
Musculoskeletal 268199 268199 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture of lumbar spine (same points as the control) with sensory discrimination (subjects watch the acupuncture point via a mirror)
Detail:
All the chosen points are designed to represent the most common and practical local acupuncture points for the treatment of low back pain. A total of 14 points will be inserted for each intervention.
Considering subjects will be in different sizes and shapes, instead of using metric system to standardise points their thumb width (cun, unit of measuring points in acupuncture) will be measured by using a cunometer (a measuring instrument similar to a clipper that is used to find thumb width/cun). The spinous processes of lumbar spine will be used as the point of reference and the cunometer will be employed to find the acupuncture
points. The points will be marked on the subjects lumbar region with skin safe pen and left for the duration of both intervention.
The points are mostly traditional points thus they run over a meridian (Urinary Bladder). Four of the points do not run over the meridian and they are common Trigger or Ah Shi points.All these points have been used in numerous large trials of acupuncture for low back pain. The Depth of penetration will be standardised to only 15mm and insertion will be directed obliquely towards the spinous process. To standardise the depth all needles will be exactly 15mm in length and they are completely inserted in both interventions.
In the experimental intervention arm subjects will participate in a sensory discrimination training programme similar to that used by Moseley et al. (2008b) in the management of CRPS. Subjects will be shown a picture of the back with the position of each needle numbered. The clinician will manipulate a single needle for a few seconds in random order and the subject will be required to nominate which needle is being stimulated. This will be performed with visualisation of the back via a mirror in the first 10 minutes and progressed to without a mirror in the last 10 minutes.

Each intervention sesssion is 20 minutes in duration with a 10 minutes wash out periods between each intervention. Subjects will have to attend one appointment. During the appointment they will recieve the two interventions.
Intervention code [1] 266746 0
Treatment: Other
Comparator / control treatment
Acupuncture of Lumbar spine without any sensory discrimination. ISQ points as experimental group.

Detail:
In the control intervention arm subjects will be asked to lay comfortably and relaxed and not attend to the needles and there will be minimal interaction with the treating therapist while the needles are in and while the therapist manipulates the needles for 20 minutes.

Each intervention sesssion is 20 minutes in duration with a 10 minutes wash out periods between each intervention. Subjects will only have to attend one appointment. During the appointment they will recieve the two interventions.
Control group
Active

Outcomes
Primary outcome [1] 268950 0
Lower Back Pain assessed using a Visual Analogue Scale after 10 most provocative active movement.
Timepoint [1] 268950 0
Outcme is assessed immediately before and after treatment and control.
Secondary outcome [1] 276707 0
None
Timepoint [1] 276707 0
None

Eligibility
Key inclusion criteria
Subjects with Nonspecific Lower Back Pain
Inclusion Criteria
Low back pain as the predominant problem
At least 6 months duration of current episode
Non-specific in nature
A score of 4 or more on the SF36 bodily pain scale (modified to read LBP)
18 years or older
Adequate knowledge of English to complete the forms
Ability to provide written informed consent
Otherwise well
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Specific low back pain (infection, malignancy, inflammatory disease, etc)
Nerve root pain
Pregnant or less than 6 months post partum
Unstable psychiatric condition
Recent back surgery (within previous 12 months)
Judged by treating clinician to be unsuitable for acupuncture 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)
Subjects will be randomised by concealed randomisation.A random sequence of 25 numbers will be generated by an independent person not involved in the study, with each number in the sequence sealed in consecutively numbered opaque envelopes and an odd/even allocation to group used to randomise subjects to either experimental arm then contorl or’ or ‘control arm then experimental arm’.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To generate the sequence for treatment a computer software will be used. The mothod will be computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267240 0
University
Name [1] 267240 0
Curtin University
Country [1] 267240 0
Australia
Primary sponsor type
Individual
Name
M Sadegh Sam Abbaszadeh
Address
Curtin University
Kent Street, Bentley, Perth
Western Australia. 6102
Country
Australia
Secondary sponsor category [1] 266313 0
Individual
Name [1] 266313 0
Dr Anne Smith
Address [1] 266313 0
Curtin University
Kent Street, Bentley, Perth
Western Australia. 6102
Country [1] 266313 0
Australia
Other collaborator category [1] 252062 0
Individual
Name [1] 252062 0
Dr Ben Wand
Address [1] 252062 0
University of Notre Dame
13-19 Mouat Street
Fremantle WA 6160
Country [1] 252062 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269231 0
Curtin Human Ethic Commitee
Ethics committee address [1] 269231 0
Curtin University
Kent Street
Bentley WA 6102
Ethics committee country [1] 269231 0
Australia
Date submitted for ethics approval [1] 269231 0
20/06/2011
Approval date [1] 269231 0
Ethics approval number [1] 269231 0

Summary
Brief summary
Evidence obtained from this study may further increase our understanding of the CLBP experience and may potentially help us to develop a more effective treatment for management of this problem. Furthermore, it may also give us a new insight about the mechanism of acupuncture/dry needling.
We hypothesis that CLBP patients will derive greater benefit from acupuncture when it is used as a sensory discrimination training tool
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32727 0
Address 32727 0
Country 32727 0
Phone 32727 0
Fax 32727 0
Email 32727 0
Contact person for public queries
Name 15974 0
Sam Abbaszadeh
Address 15974 0
328 Warwick Road Warwick WA 6023
Country 15974 0
Australia
Phone 15974 0
+61 402842712
Fax 15974 0
Email 15974 0
[email protected]
Contact person for scientific queries
Name 6902 0
Sam Abbaszadeh
Address 6902 0
328 Warwick Road Warwick WA 6023
Country 6902 0
Australia
Phone 6902 0
+61 402842712
Fax 6902 0
Email 6902 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.