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Completed

NCT Number: NCT03227952

Sensory Stimulation in Fibromyalgia

The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vibrotactile Stimulation

Device

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Jesus Pujol

Other

Registry information

Official study title

Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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