Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000561785
Ethics application status
Approved
Date submitted
13/05/2013
Date registered
17/05/2013
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of repetitive transcranial magnetic stimulation in the treatment of fibromyalgia
Scientific title
Repetitive transcranial magnetic stimulation in the treatment of fibromyalgia
Secondary ID [1] 282493 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia

 289137 0
Chronic Pain 289140 0
Mental Health 289141 0
Condition category
Condition code
Musculoskeletal 289473 289473 0 0
Other muscular and skeletal disorders
Mental Health 289474 289474 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repetitive Transcranial Magnetic Stimulation (rTMS).

rTMS will be administered using the Magventure Magpro or NeuroStar TMS Therapy System (Neuronetics Inc). Prior to the administration of rTMS, each participants resting motor threshold (RMT) will be determined according to standard published methods.

Participants will undergo a total of 20 treatments, daily (mon-fri) for 4 weeks. In each treatment, participants will receive 75 trains of 4 second duration with a frequency of 10 Hz. Stimulation intensity will be set at 120% RMT and will applied to the dorsolateral prefrontal cortex.

The above protocol is in compliance with current published rTMS safety guidelines.

Participants will undergo an assessment at baseline, at the end of weeks 1, 2, 3 and 4, and at a subsequent one -month follow-up. The clinical outcome of rTMS treatments will be determined through these assessments.
Intervention code [1] 287147 0
Treatment: Devices
Comparator / control treatment
Participants allocated to the sham condition will be administered sham rTMS that will be identical to the active condition (described above) except no stimulation will be applied.
Control group
Placebo

Outcomes
Primary outcome [1] 289576 0
Change in severity and impact of pain as measured by the Short-form McGill Pain Questionnaire and the Brief Pain Inventory.
Timepoint [1] 289576 0
At the end of treatment course (week 4).
Primary outcome [2] 289595 0
Change in quality of life as measured by the Short-form 36 Health Survey and the Fibromyalgia impact questionnaire.
Timepoint [2] 289595 0
End of treatment course (week 4).
Secondary outcome [1] 302760 0
Change in severity of depressive symptoms as shown by score of the Beck Depression Inventory (BDI).
Timepoint [1] 302760 0
End of treatment course (week 4).
Secondary outcome [2] 339111 0
Change in Multi-dimensional Fatigue Inventory score
Timepoint [2] 339111 0
Baseline compared to end of treamtent at 4 weeks and 1 month follow up
Secondary outcome [3] 339112 0
Change in Pain Catastrophisation Scale
Timepoint [3] 339112 0
Baseline compared to end of treatment at 4 weeks and 1 month follow up
Secondary outcome [4] 339113 0
Change in Beck Anxiety Inventory and State-Trait Anxiety Inventory scores
Timepoint [4] 339113 0
Baseline compared to end of treatment (4 weeks) compared to follow-up (1 month post treatment).

Eligibility
Key inclusion criteria
Participants will be included if they:
* are aged between 18-65 years,
* meet American College of Rheumatology Fibromyalgia Scale (2010) diagnostic criteria for Fibromyalgia
* have experienced symptoms for > 6 months
* have had no change in medication in the four weeks prior to trial initiation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of epilepsy or seizure disorder
* History of serious head injury
* Metal in the head (outside of the mouth)
* Medical implants in the body
* History or diagnosis of neurological/psychiatric illness
* Specific pathological entities, such as infection, neoplasm, metastasis, osteoporosis, rheumatoid arthritis or fracture
* Additional co-existing musculoskeletal conditions
* Pregnant
* Professional driver or machine operator.

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
40 participants with fibromyalgia will be recruited into the trial. As we are expecting that our DLPFC rTMS treatment course will result in a significant change in clinical outcomes (effect sizes of reduced pain intensity, secondary pain outcomes and quality of life reported by Mhalla and colleagues (2011) were generally around d = 0.80) we are predicting at least a moderate to large effect size. Therefore, our chosen sample size should provide power of 90% to detect (a = .05, two-tailed) moderate to large effect sizes (f = 0.50), while allowing for a drop-out rate of 15-20%, in a repeated measures ANOVA.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We have concluded the study prior to meeting our recruitment target as we exceeded the planned interval of the study and had secured funding for a next step-investigation.
Date of first participant enrolment
Anticipated
12/08/2013
Actual
25/10/2013
Date of last participant enrolment
Anticipated
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
24/05/2017
Sample size
Target
40
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287277 0
University
Name [1] 287277 0
Monash University, Monash Alfred Psychiatry Research Center
Country [1] 287277 0
Australia
Primary sponsor type
Individual
Name
Dr Bernadette Fitzgibbon
Address
Monash Alfred Psychiatry Research Center,
Level 4, 607 St Kilda Road
Melbourne 3004 VIC
Country
Australia
Secondary sponsor category [1] 286030 0
None
Name [1] 286030 0
Address [1] 286030 0
Country [1] 286030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289257 0
Alfred Health
Ethics committee address [1] 289257 0
The Alfred, Commercial Rd, Melbourne, Victoria, 3004
Ethics committee country [1] 289257 0
Australia
Date submitted for ethics approval [1] 289257 0
27/05/2013
Approval date [1] 289257 0
04/07/2013
Ethics approval number [1] 289257 0
249/13
Ethics committee name [2] 289757 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 289757 0
Building 3E,
Room 111,
Clayton Campus,
Wellington Road,
Clayton
VIC 3800
Ethics committee country [2] 289757 0
Australia
Date submitted for ethics approval [2] 289757 0
05/07/2013
Approval date [2] 289757 0
10/07/2013
Ethics approval number [2] 289757 0
CF13/2067 - 2013001080
Ethics committee name [3] 289758 0
Monash Health
Ethics committee address [3] 289758 0
Monash Medical Center
246 Clayton Rd,
Clayton
VIC 3168
Ethics committee country [3] 289758 0
Australia
Date submitted for ethics approval [3] 289758 0
11/07/2013
Approval date [3] 289758 0
25/07/2013
Ethics approval number [3] 289758 0
13253X

Summary
Brief summary
Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is an approved treatment option for patients with depression in the Canada and several EU nations, with significant evidence demonstrating greater clinical outcomes following longer treatment courses. For patients with fibromyalgia, studies suggest rTMS may also offer a novel treatment approach for pain relief. However these effects are short-lasting thereby limiting its clinical application. Yet no studies to date have explored the effects of a treatment course of similar duration to that used in depression. In addition, there is a dearth of literature exploring target sites other than the motor cortex, such as the dorsolateral prefrontal cortex (DLPFC); a brain region directly implicated in the control of pain perception. In the proposed world-first study, we will carry-out a randomised double-blind placebo-controlled trial to assess the use of an rTMS treatment course applied to the DLPFC in patients who suffer from fibromyalgia. To do so, we will recruit a total of 40 patients with a diagnosis of fibromyalgia who will undergo a blind 4-week acute rTMS daily treatment course. We expect our proposed treatment course of rTMS to the DLPFC in patients with fibromyalgia will provide a model for an interventional treatment course that may be extended to other pain syndromes. Thereby reducing dependence on pharmaceutical treatments in patients who suffer from chronic pain and increasing quality of life for the millions of chronic pain sufferer's worldwide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40002 0
Dr Bernadette Fitzgibbon
Address 40002 0
Monash Alfred Psychiatry Research Center
Level 4, 607 St Kilda Road
Melbourne 3004 VIC
Country 40002 0
Australia
Phone 40002 0
+61 3 90769860
Fax 40002 0
Email 40002 0
[email protected]
Contact person for public queries
Name 40003 0
Dr Bernadette Fitzgibbon
Address 40003 0
Monash Alfred Psychiatry Research Center
Level 4, 607 St Kilda Road
Melbourne 3004 VIC
Country 40003 0
Australia
Phone 40003 0
+61 3 90769860
Fax 40003 0
Email 40003 0
[email protected]
Contact person for scientific queries
Name 40004 0
Dr Bernadette Fitzgibbon
Address 40004 0
Monash Alfred Psychiatry Research Center
Level 4, 607 St Kilda Road
Melbourne 3004 VIC
Country 40004 0
Australia
Phone 40004 0
+61 3 90769860
Fax 40004 0
Email 40004 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
EmbaseEvidence for the improvement of fatigue in fibromyalgia: A 4-week left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation randomized-controlled trial.2018https://dx.doi.org/10.1002/ejp.1213
N.B. These documents automatically identified may not have been verified by the study sponsor.