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Trial registered on ANZCTR


Registration number
ACTRN12614001247662
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
28/11/2014
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of non-invasive brain stimulation on chronic arm pain
Scientific title
The effects of non-invasive brain stimulation on pain and the nociceptive system in people with chronic neuropathic pain
Secondary ID [1] 285644 0
Nil
Universal Trial Number (UTN)
U1111-1138-3092
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic neuropathic arm pain 293485 0
Condition category
Condition code
Neurological 293763 293763 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation. One session per day for 5 days, 20 minutes per session, 1 mA anodal stimulation, delivered by a HDC Kit (Magstim).
Intervention code [1] 290583 0
Treatment: Devices
Comparator / control treatment
Sham transcranial direct current stimulation. One session per day for 5 days, 20 minutes per session, 0 mA anodal stimulation, delivered by a HDC Kit (Magstim).
Control group
Placebo

Outcomes
Primary outcome [1] 293560 0
Arm pain assessed using Short-Form McGill Pain Questionnaire vII, Brief Pain Inventory.
Timepoint [1] 293560 0
1 week
Secondary outcome [1] 311355 0
Mechanical pressure-pain threshold over hand and non-painful region assessed using force algometer (Somedic).
Timepoint [1] 311355 0
1 week
Secondary outcome [2] 311356 0
Upper limb function assessed using Disabilities of Arm, Shoulder and Hand (DASH).
Timepoint [2] 311356 0
1 week
Secondary outcome [3] 311357 0
Heat pain threshold over hand and non-painful region assessed using thermal stimulator (Somedic) and probe.
Timepoint [3] 311357 0
1 week
Secondary outcome [4] 311358 0
Temporal summation of mechanical pain assessing using repetitive pinprick stimulation (10 stimuli) over hand and non-painful region.
Timepoint [4] 311358 0
1 week

Eligibility
Key inclusion criteria
Diagnosis of neuropathic pain in the upper limb by a specialist pain physician, stable chronic pain for at least the preceding 6 months, taking consistent analgesic medication for the preceding 2 months, report a pain score greater than or equal to 3 (0 = no pain and 10 = worst possible pain) during the week preceding the baseline period.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe or unstable medical or psychiatric conditions

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 6470 0
New Zealand
State/province [1] 6470 0

Funding & Sponsors
Funding source category [1] 290228 0
Charities/Societies/Foundations
Name [1] 290228 0
Neurological Foundation of New Zealand
Address [1] 290228 0
PO Box 110022, Auckland City Hospital, Auckland 1148
Country [1] 290228 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288936 0
None
Name [1] 288936 0
Address [1] 288936 0
Country [1] 288936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291929 0
Health and Disability Ethics Committee
Ethics committee address [1] 291929 0
Ethics committee country [1] 291929 0
New Zealand
Date submitted for ethics approval [1] 291929 0
Approval date [1] 291929 0
03/05/2013
Ethics approval number [1] 291929 0
Ethics committee name [2] 291930 0
Auckland University of Technology Ethics COmmittee
Ethics committee address [2] 291930 0
Ethics committee country [2] 291930 0
New Zealand
Date submitted for ethics approval [2] 291930 0
Approval date [2] 291930 0
Ethics approval number [2] 291930 0

Summary
Brief summary
Electrical stimulation of the brain has recently been used as a treatment for people with long-term pain conditions. Currently, it is not certain how brain stimulation is able to reduce pain in these people. The current project proposes to examine changes in the nervous system of people with long-term arm pain who receive a 5-day brain stimulation intervention. The study findings will provide more information on how brain stimulation works and the types of patients who will benefit most from this treatment. This will facilitate the clinical use of brain stimulation for the treatment of long-term pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52642 0
A/Prof Gwyn Lewis
Address 52642 0
Health and Rehabilitation Research Institute
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 52642 0
New Zealand
Phone 52642 0
+64 9 921 9999
Fax 52642 0
Email 52642 0
gwyn.lewis@aut.ac.nz
Contact person for public queries
Name 52643 0
A/Prof Gwyn Lewis
Address 52643 0
Health and Rehabilitation Research Institute
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 52643 0
New Zealand
Phone 52643 0
+ 64 9921 9999
Fax 52643 0
Email 52643 0
gwyn.lewis@aut.ac.nz
Contact person for scientific queries
Name 52644 0
A/Prof Gwyn Lewis
Address 52644 0
Health and Rehabilitation Research Institute
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 52644 0
New Zealand
Phone 52644 0
+64 9 921 9999
Fax 52644 0
Email 52644 0
gwyn.lewis@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 314 0
Lewis GN, Rice DA, McNair PJ, Kluger M. 2018. Transcranial direct current stimulation for upper limb neuropathic pain: A double-blind randomized controlled trial. European Journal of Pain 22(7):1312-132.
Attachments [1] 314 0
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary