ANZCTR - Registration

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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

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Musculoskeletal

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]

Treatment: Devices

Comparator / control treatment

Placebo treated using sham device.

Control group

Placebo

Outcomes

Primary outcome [1]

Pain Reduction

This outcome measures will be measured by tenderpoint count, visual analogue scales and self-report Fibromyalgia Impact Questionnaire (FIQ)

Timepoint [1]

Baseline, 3 weeks and 6 weeks.

Secondary outcome [1]

Anxiety Reduction)

Measured by Depression and Anxiety Symptoms questionnaire (DAS) and the Inventory of Depressive Symptoms (IDS)

Timepoint [1]

Baseline, 3 weeks and 6 weeks.

Secondary outcome [2]

Reduction of Insomnia

Quality of sleep measured by the Pittsburg Sleep Inventory

Timepoint [2]

Baseline, 3 weeks and 6 weeks.

Secondary outcome [3]

Impact of Illness - Fibromyalgia Impact Questionnaire

Timepoint [3]

Baseline, 3 weeks and 6 weeks.

Secondary outcome [4]

Reduction in Depressive Symptoms

Depression measured by Depression and Anxiety Symptoms questionnaire (DAS) and the Inventory of Depressive Symptoms (IDS)

Timepoint [4]

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]

University

Name [1]

Deakin University

Address [1]

Burwood Hwy,
Burwood, VICTORIA 3125

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics

Ethics committee address [1]

Burwood Hwy
Burwood 3125
Victoria, AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/08/2009

Approval date [1]

10/08/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Ms Melissa Seedy

Address

Deakin University
Burwood Hwy
Burwood, VICTORIA 3125

Country

Australia

Phone

+61 3 9251-7749

Fax

Email

[email protected]

Contact person for scientific queries

Name

Ms Melissa Seedy

Address

Deakin University
Burwood Hwy
Burwood, VICTORIA 3125

Country

Australia

Phone

+61 3 9251-7749

Fax

Email

[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.