Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Sensory Stimulation in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227952
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jesus Pujol, Neurovoxel SLP

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Vibrotactile stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: a sham device identical to the active device
Primary Purpose: Treatment
Official Title: Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Active treatment
Vibrotactile sensory stimulation
Device: Vibrotactile stimulation
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).

Sham Comparator: Sham
Identical device. No vibration
Device: Vibrotactile stimulation
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 Measures :
  1. 101-point verbal rating scale (VRS) [ Time Frame: 3 weeks ]
    Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).


Secondary Outcome Measures :
  1. Associated symptom improvement [ Time Frame: 3 weeks ]
    Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227952


Locations
Layout table for location information
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Jesus Pujol
Investigators
Layout table for investigator information
Principal Investigator: Jesus Pujol, MD Hospital del Mar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jesus Pujol, Principal Investigator, Neurovoxel SLP
ClinicalTrials.gov Identifier: NCT03227952    
Other Study ID Numbers: MOT6932
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases