Fibromyalgia
Conditions
Interventions
(1) AT-02 group AT-02 is an investigational medical device (unapproved) that concurrently produces multiple magnetic fields to promote pain relief.
(2) S-01 Sham group (Sham Control) A device that i
Sponsors
P-Mind Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Age:Patients aged 20 years of age or older - <80 years (at the time of obtaining informed consent) (2)Patients meeting the diagnostic criteria for fibromyalgia (1990) from the American College of Rheumatology (ACR) (3)Patients with NRS 4 or more and persistent pain for 3 months or longer (4)Patients from whom written informed consent can be directly obtained
Exclusion criteria
Exclusion criteria: (1) Patients with expected survival less than 3 years due to malignancies or other reasons (2) Patients using life-sustaining electrical medical devices, such as artificial heart-lung devices (3) Patients using affixed electrical medical devices, such as ECG recorders (4) Patients who are participating in another clinical trial for a pharmaceutical product or medical device (5) Patients with dementia that seriously disturbs activities of daily life (6) Females who wish to become pregnant or are presently pregnant or nursing mothers (if the patient is a woman of childbearing potential, a pregnancy test must be performed) and others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the mean NRS in the Baseline Observation Period (6 days from Day -2 to Day 7 of the Baseline Observation Period) and the mean NRS at Week 8 of the Treatment Period | — |
Countries
Japan
Contacts
Public ContactMakoto Sawaguchi
Mebix Inc. Research Promotion Division
Outcome results
None listed