Back to resultsSensory Stimulation in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vibrotactile stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active treatment
Sham
Arm Description
Vibrotactile sensory stimulation
Identical device. No vibration
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Associated symptom improvement
Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03227952
Brief Title
Sensory Stimulation in Fibromyalgia
Official Title
Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jesus Pujol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
a sham device identical to the active device
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Vibrotactile sensory stimulation
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Identical device. No vibration
Intervention Type
Device
Intervention Name(s)
Vibrotactile stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
101-point verbal rating scale (VRS)
Description
Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Associated symptom improvement
Description
Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Pujol, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31200775
Citation
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.
Results Reference
derived
Learn more about this trial
Sensory Stimulation in Fibromyalgia
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