Status:
COMPLETED
Sensory Stimulation in Fibromyalgia
Lead Sponsor:
Jesus Pujol
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.
Detailed Description
The trial will last up to 8 weeks for each subject and includes: Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or actual) Vibrotactile sensory stimulation wi...
Eligibility Criteria
Inclusion
- A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172)
- Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
- Diagnoses established by an expert on fibromyalgia.
- Stable treatment of chronic use.
- Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
Exclusion
- Generalized inflammatory articular or rheumatic disease.
- Heavily exercise for 12 hours prior to fMRI assessment
- Severe, non-stable medical, endocrinological or neurological disorder.
- Psychotic disorder or drug abuse.
Key Trial Info
Start Date :
September 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03227952
Start Date
September 4 2017
End Date
May 31 2018
Last Update
October 17 2018
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003