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Trial registered on ANZCTR


Registration number
ACTRN12616001682437
Ethics application status
Approved
Date submitted
15/09/2016
Date registered
7/12/2016
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcranial direct current stimulation (tDCS) combined with pain cognition training for fibromyalgia
Scientific title
Anodal dorsolateral prefrontal cortex (DLPFC) tDCS combined with pain cognition training for fibromyalgia: A pilot randomised control trial
Secondary ID [1] 290161 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 300282 0
Condition category
Condition code
Musculoskeletal 300150 300150 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
transcranial direct current stimulation (tDCS) plus pain cognition training

Participants will undergo 20 treatment sessions across 4 weeks (Monday-Friday).

At each treatment session, participants will undergo tDCS. Participants will be randomly allocated to receive active or sham tDCS. Active tDCS will be applied using two 35cm2 electrodes with a electrical current of 0.057mA/cm2 for 20 minutes. The anode electrode will be placed over the left DLPFC, and the cathode electrode over the right supraorbital region.

Three times per week (i.e. tues-thurs for each of the four weeks), participants will engage in pain cognition training for 30 minutes immediately following tDCS . The training involves the use of a self-administered paper workbook that allows participants to identify the triggers and modifiers of their pain, and will be used in conjunction with a paper-based pain education resource. Both the workbook and the pain education resource are developed by the Neuro Orthopaedic Institute Group.

tDCS and Pain Cognition training will be administered/overseen by a trained researcher or clinician at Monash Alfred Psychiatry Research Centre.

Fidelty of tDCS blinding: both the subject and investigator administering stimulation will be blinded. An independent researcher will assign participants codes for active and sham treatments. The tDCS administrator simply enters the code into the machine which will conduct an active or sham session according to the code entered. We will also be conducting blinding questionnaires with participants to assess the fidelity of the blinding.

Intervention code [1] 295915 0
Treatment: Other
Intervention code [2] 296555 0
Treatment: Devices
Comparator / control treatment
sham transcranial direct current stimulation (tDCS) plus pain cognition training

Participants will undergo the same protocol as the intervention group, except the tDCS current will be turned off after approximately 30 seconds.
Control group
Placebo

Outcomes
Primary outcome [1] 299642 0
Fibromyalgia Impact Questionnaire
Timepoint [1] 299642 0
Baseline versus 4 weeks versus one month follow up.
Secondary outcome [1] 327724 0
Pain Intensity and Unpleasantness (NPRS, 0-10);
Timepoint [1] 327724 0
Baseline versus 4 weeks versus one month follow up.
Secondary outcome [2] 327798 0
Severity and impact of pain assessed using Brief Pain Inventory


Timepoint [2] 327798 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [3] 327799 0
Description of pain quality (i.e. sensory and/or affective) and pain intensity assessed using Short-Form McGill Pain Questionnaire
Timepoint [3] 327799 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [4] 327800 0
Self-reported health assessed by Short-form 36 Version 2
Timepoint [4] 327800 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [5] 327801 0
Fatigue assessed by Multifaceted Fatigue Inventory;
Timepoint [5] 327801 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [6] 327802 0
Depression assessed by Beck Depression Inventory-II;
Timepoint [6] 327802 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [7] 327803 0
Anxiety assessed by Anxiety Inventory;
Timepoint [7] 327803 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [8] 327804 0
Depression, Anxiety and Stress assessed by Depression, Anxiety and Stress Scale 21;
Timepoint [8] 327804 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [9] 327805 0
Sleep assessed by Medical Outcomes Study Sleep Outcomes;
Timepoint [9] 327805 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [10] 327806 0
Pain catastrophisation assessed by Pain Catastrophising Scale;
Timepoint [10] 327806 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [11] 327807 0
Pain Self-Efficacy assessed by Pain Self-Efficacy Questionnaire;
Timepoint [11] 327807 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [12] 327808 0
Pain Vigilance and Awareness assessed by Pain Vigilance and Awareness Scale;
Timepoint [12] 327808 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [13] 327809 0
Pain anxiety assessed by Pain Anxiety Symptom Scale;
Timepoint [13] 327809 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [14] 327810 0
Pain Beliefs and Perceptions assessed by Pain Beliefs and Perceptions Inventory;
Timepoint [14] 327810 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [15] 327811 0
Pain education assessed by Neurophysiology of Pain Questionnaire
Timepoint [15] 327811 0
Baseline vs 4 weeks vs one month follow up
Secondary outcome [16] 345524 0
Cortical function via Transcranial magnetic stimulation (TMS) with concurrent electroencephalogram (EEG) recording (TMS-EEG)
Timepoint [16] 345524 0
Baseline versus 4 weeks versus one-month follow up

Eligibility
Key inclusion criteria
Patients will be included if they:
- A formal diagnosis of fibromyalgia
- Aged between 18 and 70 years old
- Have no increase or initiation of new medication therapy in the 8 weeks prior to screening and maintain existing medication regimen throughout this study’s treatment course.

Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who:
- Have a medical history of any a neurological disorder (including epilepsy and head injury) or are currently pregnant or lactating.
- Have a current DSM-V diagnosis of any psychiatric condition; excluding depression, anxiety and PTSD, unless identified as primary disorder.
- Any contraindication to transcranial electrical stimulation; including presence of metal inside the head (excluding dental work) or body.

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?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 294528 0
University
Name [1] 294528 0
Monash University
Address [1] 294528 0
MAPrc
4/607 St Kilda Road
Melbourne
VIC 3004
Country [1] 294528 0
Australia
Primary sponsor type
Individual
Name
Bernadette Fitzgibbon
Address
MAPrc
4/607 St Kilda Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 293391 0
None
Name [1] 293391 0
Address [1] 293391 0
non
Country [1] 293391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295961 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 295961 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 295961 0
Australia
Date submitted for ethics approval [1] 295961 0
15/09/2016
Approval date [1] 295961 0
03/11/2016
Ethics approval number [1] 295961 0

Summary
Brief summary
Fibromyalgia is a complex chronic disorder affecting 2-4% of the population. It is a debilitating condition that has substantial consequences for the individual, their family and the economy. Current treatments are predominantly pharmacological interventions with either no evidence or little support for efficacy and/or associated with significant side effects. There is therefore an urgent need to develop non-pharmaceutical treatments. One potential option is pain cognition training, which is thought to work via the reconceptualization of maladaptive pain cognitions. Although a promising area, research in this field has shown only moderate effects at best. In this study, we will examine whether combining transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, to pain cognition training enhances treatment outcomes by acting on synergistic neural processes. If successful in finding that the combined treatment is better than pain cognition training alone, this study has the potential to offer better patient care than is currently available.

Forty adult participants with a diagnosis fibromyalgia will be recruited for this randomized, double-blind, placebo-controlled study. Participants will be randomized into one of two treatment groups (active tDCS with pain cognition training, or sham tDCS with pain cognition training) for a 4 week daily (Monday-Friday) treatment course. At each treatment session participants will receive 20 minutes of active tDCS or sham (placebo) tDCS, followed by 30 minutes of cognition training, 3 times per treatment week (i.e. tues-thurs for each of the four weeks). Participants will complete symptom-related questionnaires and undergo a pain assessment at baseline, at the end of each treatment week (1-4), as well as at a follow-up appointment one-month following the completion of treatment. Data collected from these questionnaires and the pain assessments will be compared between the active tDCS group and placebo tDCS group using repeated measures analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69074 0
Dr Bernadette Fitzgibbon
Address 69074 0
Monash Alfred Psychiatry Research Centre
4/607 St Kilda Road
Melbourne
VIC 3004
Country 69074 0
Australia
Phone 69074 0
+61 3 9076 9860
Fax 69074 0
Email 69074 0
bernadette.fitzgibbon@monash.edu
Contact person for public queries
Name 69075 0
Dr Bernadette Fitzgibbon
Address 69075 0
Monash Alfred Psychiatry Research Centre
4/607 St Kilda Road
Melbourne
VIC 3004
Country 69075 0
Australia
Phone 69075 0
+61 3 9076 9860
Fax 69075 0
Email 69075 0
bernadette.fitzgibbon@monash.edu
Contact person for scientific queries
Name 69076 0
Dr Bernadette Fitzgibbon
Address 69076 0
Monash Alfred Psychiatry Research Centre
4/607 St Kilda Road
Melbourne
VIC 3004
Country 69076 0
Australia
Phone 69076 0
+61 3 9076 9860
Fax 69076 0
Email 69076 0
bernadette.fitzgibbon@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval for this
What supporting documents are/will be available?
No other documents available
Summary results
No Results