Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital
About this trial
Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is 18 to 80 years old, including both male and female subjects.
Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Disqualifiers
Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
Subject has major psychiatric disorder required hospitalization in the last 3 months.
Subject has active infection at the site of device application.
Subject has recurrent syncope symptoms within the past three months.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Vagus Nerve Stimulation
Device30 minutes stimulation, twice per day for 4 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous Vagus Nerve Stimulation(tVNS)Experimental treatment 1 intervention
Group B: Sham Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
A modified McGill Pain Questionnaire
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
Time frame
at 0,4, weeks of the study,Secondary outcomes
1
Multidimensional Fatigue Inventory
Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
Time frame
at 0,4,8 weeks of the study2
Medical Outcomes Study Sleep Scale
sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
Time frame
at 0,4,8 weeks of the study3
Revised Fibromyalgia Impact Questionnaire
Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
Time frame
at 0,4,8 weeks of the study4
Medical Outcomes Study Questionnaire Short Form 36
Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
Time frame
at 0, 4, 8 weeks of the studySponsors and contacts
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Source ClinicalTrials.gov