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Sensory Stimulation in Fibromyalgia

Sponsor
Jesus Pujol (Other)
Overall Status
Completed
CT.gov ID
NCT03227952
Collaborator
(none)
77
Enrollment
1
Location
2
Arms
8.8
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vibrotactile stimulation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Parallel AssignmentParallel 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 :
Sep 4, 2017
Actual Primary Completion Date :
May 31, 2018
Actual Study Completion Date :
May 31, 2018

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 101-point verbal rating scale (VRS) [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 [3 weeks]

    Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital del Mar Barcelona Spain 08003

Sponsors and Collaborators

  • Jesus Pujol

Investigators

  • Principal Investigator: Jesus Pujol, MD, Hospital del Mar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jesus Pujol, Principal Investigator, Neurovoxel SLP
ClinicalTrials.gov Identifier:
NCT03227952
Other Study ID Numbers:
  • MOT6932
First Posted:
Jul 24, 2017
Last Update Posted:
Oct 17, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes

Study Results

No Results Posted as of Oct 17, 2018