Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03227952
NCT03227952
Completed
N/A

Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients

Jesus Pujol1 site in 1 country77 target enrollmentSeptember 4, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Jesus Pujol
Enrollment
77
Locations
1
Primary Endpoint
101-point verbal rating scale (VRS)
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 4, 2017
End Date
May 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Jesus Pujol
Responsible Party
Sponsor Investigator
Principal Investigator

Jesus Pujol

Principal Investigator

Neurovoxel SLP

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Associated symptom improvement(3 weeks)

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
N/A
The Investigation of the Effectiveness of Vibratory Stimulation on Upper Limb Function, Pain and Sensation in Patients With Stroke.Stroke
NCT05727826Yeditepe University10
Completed
N/A
Functional MRI Study of Vibrotactile Stimulation Effects in FibromyalgiaFibromyalgia
NCT03785535Neurovoxel SLP60
Recruiting
N/A
Effect of Vibrotactile Stimulation in Lateral EpicondylitisLateral EpicondylitisVibration TherapyPhysiotherapy
NCT06674668Medipol University33
Active, Not Recruiting
N/A
Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's DiseaseParkinson's Disease
NCT05830110Synergic Medical Technologies, Inc.30
Not Yet Recruiting
N/A
TO assess the effect of vibration and low level laser therapy on the amount of IL1- Beta, IL-8 andorthodontic tooth movement
CTRI/2022/08/044842Dr Aastha Purohit