Sensory Stimulation in Fibromyalgia
Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
September 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedOctober 17, 2018
October 1, 2018
9 months
July 18, 2017
October 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
101-point verbal rating scale (VRS)
Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).
3 weeks
Secondary Outcomes (1)
Associated symptom improvement
3 weeks
Study Arms (2)
Active treatment
ACTIVE COMPARATORVibrotactile sensory stimulation
Sham
SHAM COMPARATORIdentical device. No vibration
Interventions
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
Eligibility Criteria
You may qualify if:
- A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jesus Pujollead
Study Sites (1)
Hospital del Mar
Barcelona, 08003, Spain
Related Publications (1)
Pujol J, Ramos-Lopez D, Blanco-Hinojo L, Pujol G, Ortiz H, Martinez-Vilavella G, Blanch J, Monfort J, Deus J. Testing the effects of gentle vibrotactile stimulation on symptom relief in fibromyalgia. Arthritis Res Ther. 2019 Jun 14;21(1):148. doi: 10.1186/s13075-019-1932-9.
PMID: 31200775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Pujol, MD
Hospital del Mar
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- a sham device identical to the active device
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 24, 2017
Study Start
September 4, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
October 17, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share