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Trial registered on ANZCTR


Trial ID
ACTRN12612001155886
Ethics application status
Approved
Date submitted
14/05/2012
Date registered
31/10/2012
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the role of transcranial direct current stimulation for pain relief in fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome patients
Scientific title
Investigating the role of transcranial direct current stimulation for pain relief in fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome patients - Deakin University
Secondary ID [1] 280477 0
Nil
Secondary ID [2] 280662 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia Syndrome 286455 0
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome 286456 0
Condition category
Condition code
Other 286714 286714 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
transcranial direct current stimulation (tDCS) will be administered (.8mA) 20 mins daily for 15 consecutive days (not including weekends). The current will be gradually switched on and off over a 30sec period (ramped) at the start and end of the stimulation period.
Intervention code [1] 284842 0
Treatment: Devices
Comparator / control treatment
Sham tDCS - Current will be ramped on and then the tDCS machine will switch itself off after 30 secs (though the display will remain the same to allow for double-blinding).
Control group
Placebo

Outcomes
Primary outcome [1] 287107 0
Pain assessed by visual analog scale and the McGill Pain Questionnaire
Timepoint [1] 287107 0
2 weeks prior through to 3 months post intervention
Primary outcome [2] 288271 0
Transcranial magnetic stimulation - 5 pulses (intensity determined by individual's motor threshold) will be applied to M1 in order to determine changes in neural excitation/inhibition from tDCS.
Timepoint [2] 288271 0
2 weeks prior through to 3 months post intervention.
Secondary outcome [1] 297389 0
Fatigue assessed by Chalder Fatigue Scale and Fatigue Severity Scale
Timepoint [1] 297389 0
2 weeks prior through to 3 months post intervention
Secondary outcome [2] 297902 0
General illness symptoms assessed by checklist
Timepoint [2] 297902 0
2 weeks prior through to 3 months post intervention
Secondary outcome [3] 297903 0
Daily functioning assessed by the Fibromyalgia Impact Questionnaire
Timepoint [3] 297903 0
2 weeks prior through to 3 months post intervention
Secondary outcome [4] 297904 0
Depression assessed by the Depression Anxiety Stress Scales and Inventory of Depressive Symptomatology
Timepoint [4] 297904 0
2 weeks prior through to 3 months post intervention
Secondary outcome [5] 297905 0
Sleep assessed by Pittsburgh Sleep Questionnaire
Timepoint [5] 297905 0
2 weeks prior through to 3 months post intervention
Secondary outcome [6] 297906 0
Anxiety assessed by Depression Anxiety Stress Scales
Timepoint [6] 297906 0
2 weeks prior through to 3 months post intervention
Secondary outcome [7] 297907 0
Participants will be verbally asked whether they think they received the sham or active tDCS
Timepoint [7] 297907 0
At the conclusion of the 15 days of stimulation

Eligibility
Key inclusion criteria
Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome or fibromyalgia syndrome by medical practitioner associated with the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, neurological injury

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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Needed to conduct pilot study re: protocol.
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] 285230 0
University
Name [1] 285230 0
Deakin University
Address [1] 285230 0
221 Burwood Hwy
Burwood, Vic, 3125
Country [1] 285230 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy
Burwood, Vic, 3125
Country
Australia
Secondary sponsor category [1] 284098 0
None
Name [1] 284098 0
Address [1] 284098 0
Country [1] 284098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287240 0
Deakin University Human Research Ethics Commitee
Ethics committee address [1] 287240 0
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Ethics committee country [1] 287240 0
Australia
Date submitted for ethics approval [1] 287240 0
16/05/2012
Approval date [1] 287240 0
12/07/2012
Ethics approval number [1] 287240 0
2012-084

Summary
Brief summary
This study aims to seek whether longer treatment protocols than previously applied in research will result in longer-lasting and stronger improvements in pain relief in ME/CFS and FMS. The study also seeks to investigate whether pain reduction is associated with improvements in other chronic illness symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34168 0
Ms Hannah Bereznicki
Address 34168 0
Deakin University
221 Burwood Hwy
Burwood, Vic, Aus
Country 34168 0
Australia
Phone 34168 0
+61 3 5227 8715
Fax 34168 0
Email 34168 0
hannah.bereznicki@deakin.edu.au
Contact person for public queries
Name 17415 0
Ms Hannah Bereznicki
Address 17415 0
Cognitive and Exercise Neuroscience Unit
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Country 17415 0
Australia
Phone 17415 0
+61 3 92517224
Fax 17415 0
Email 17415 0
hannah.bereznicki@deakin.edu.au
Contact person for scientific queries
Name 8343 0
Ms Hannah Bereznicki
Address 8343 0
Cognitive and Exercise Neuroscience Unit
Deakin University
221 Burwood Hwy
Burwood, Vic, 3125
Country 8343 0
Australia
Phone 8343 0
+61 3 92517224
Fax 8343 0
Email 8343 0
hannah.bereznicki@deakin.edu.au