Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000711213
Ethics application status
Approved
Date submitted
9/08/2009
Date registered
17/08/2009
Date last updated
17/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double blind, randomised cross-over trial of the efficacy of cranial electrotherapy stimulation on pain in fibromyalgia
Scientific title
The efficacy of cranial electrotherapy stimulation for the reduction of pain in fibromyalgia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 243488 0
Condition category
Condition code
Alternative and Complementary Medicine 239788 239788 0 0
Other alternative and complementary medicine
Musculoskeletal 239828 239828 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We intend to recruit 30 clinically diagnosed Fibromyalgia Syndrome (FMS) patients into a double blind, randomised, placebo
controlled, cross-over study with two conditions, a placebo/sham and a treatment condition. The Alpha-Stim -Registered Trademark - cranial electrotherapy stimulator will be used for both conditions. The Alpha-Stim SCS is a hand-held device which delivers a low-intensity electric microcurrent to the brain via small electrodes, which are attached to the earlobes. This product is Food and Drug Administration U.S.A (FDA) and Therapeutic Goods Administration Australia (TGA) approved. The stimulation unit will be set at 0.5 Hertz and 100 microamperes which in most individuals, does not produce any palpable physical sensation. The sham unit will not conduct any current.
After a session of training in use of the device, participants will self-administer treatment using the Alpha-Stim unit daily for a period of one hour per day over the course of three weeks. There is no 'wash-out' period between treatment conditions.
Intervention code [1] 237107 0
Treatment: Devices
Comparator / control treatment
Placebo treated using sham device.
Control group
Placebo

Outcomes
Primary outcome [1] 240557 0
Pain Reduction

This outcome measures will be measured by tenderpoint count, visual analogue scales and self-report Fibromyalgia Impact Questionnaire (FIQ)
Timepoint [1] 240557 0
Baseline, 3 weeks and 6 weeks.
Secondary outcome [1] 257144 0
Anxiety Reduction)

Measured by Depression and Anxiety Symptoms questionnaire (DAS) and the Inventory of Depressive Symptoms (IDS)
Timepoint [1] 257144 0
Baseline, 3 weeks and 6 weeks.
Secondary outcome [2] 257145 0
Reduction of Insomnia

Quality of sleep measured by the Pittsburg Sleep Inventory
Timepoint [2] 257145 0
Baseline, 3 weeks and 6 weeks.
Secondary outcome [3] 257146 0
Impact of Illness - Fibromyalgia Impact Questionnaire
Timepoint [3] 257146 0
Baseline, 3 weeks and 6 weeks.
Secondary outcome [4] 257147 0
Reduction in Depressive Symptoms

Depression measured by Depression and Anxiety Symptoms questionnaire (DAS) and the Inventory of Depressive Symptoms (IDS)
Timepoint [4] 257147 0
Baseline, 3 weeks and 6 weeks.

Eligibility
Key inclusion criteria
Person's diagnosed with Fibromyalgia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons under 18.
Pregnant women.

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)
The study will employ a double-blind, placebo-control, crossover design.
Patients who satisfy the criteria for inclusion in the trial and who agree to participate will undergo a randomisation procedure so as to be allocated to one of two groups. Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site. Depending on the sample characteristics, we may use a block randomisation or a minimisation procedure to allocate participants to ensure comparability of the groups on variables such as age, sex, disease activity
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequences will be generated using the random number generator in MS Excel.
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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237480 0
University
Name [1] 237480 0
Deakin University
Country [1] 237480 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pacific Medistim
Address
Pacific Medistim Distributors Pty.Ltd.
PO Box 638, RUNAWAY BAY
Queensland, 4216. Australia
Country
Australia
Secondary sponsor category [1] 236964 0
None
Name [1] 236964 0
Address [1] 236964 0
Country [1] 236964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239603 0
Deakin University Human Research Ethics
Ethics committee address [1] 239603 0
Burwood Hwy
Burwood 3125
Victoria, AUSTRALIA
Ethics committee country [1] 239603 0
Australia
Date submitted for ethics approval [1] 239603 0
07/08/2009
Approval date [1] 239603 0
10/08/2009
Ethics approval number [1] 239603 0
EC 91-2009

Summary
Brief summary
We are conducting a study of a potential treatment (Alpha-Stim:Registered Trademark) for pain associated with fibromyalgia. We are looking for people who have been diagnosed with fibromyalgia who are willing to trial the Alpha-Stim: Registered Trademark Cranial Electrotherapy Stimulation (CES) device daily over a six week period.

If you do agree to participate, you will be required to attend the laboratory at Deakin Burwood Campus for three 2 hour sessions within the 6 week period of the study. The first of these sessions will be held before your first 3 weeks of CES treatment, the second after the first 3 weeks, and the third at the conclusion of your treatment. During each of these sessions, we will be measuring your levels of pain, anxiety, depression and quality of sleep using certain tests. You will be asked to fill out some questionnaires to establish the severity and impact of your symptoms. These questionnaires should take about 20 minutes to complete. We will seek information such as your age, gender and the length of time you have suffered from fibromyalgia. Pain will be measured using a device which applies light pressure to parts of the body, and a visual analogue scale, which is a questionnaire asking for your level of agreement with certain statements about your pain.
We will also measure some psychological and cognitive attributes. The tests being used are all standardized clinical measures and will be used to assess you at baseline (pre-treatment), in the middle of the 6 weeks and then again at the conclusion of the 6 week period (post-treatment).
Trial website
www.deakin.edu.au/psychology/research/ihru
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30031 0
Address 30031 0
Country 30031 0
Phone 30031 0
Fax 30031 0
Email 30031 0
Contact person for public queries
Name 13278 0
Ms Melissa Seedy
Address 13278 0
Deakin University
Burwood Hwy
Burwood, VICTORIA 3125
Country 13278 0
Australia
Phone 13278 0
+61 3 9251-7749
Fax 13278 0
Email 13278 0
[email protected]
Contact person for scientific queries
Name 4206 0
Ms Melissa Seedy
Address 4206 0
Deakin University
Burwood Hwy
Burwood, VICTORIA 3125
Country 4206 0
Australia
Phone 4206 0
+61 3 9251-7749
Fax 4206 0
Email 4206 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.