None listed
Conditions
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).
Interventions
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
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.
Sponsors
Pacific Medistim
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Person's diagnosed with Fibromyalgia
Exclusion criteria
Persons under 18. Pregnant women.
Outcome results
None listed