Fibromyalgia
Conditions
Keywords
Vagus nerve stimulation,, pain, fibromyalgia symptoms
Brief summary
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.
Detailed description
The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.
Interventions
DEVICETranscutaneous Vagus Nerve Stimulation
30 minutes stimulation, twice per day for 4 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 to 80 years old, including both male and female subjects. 2. 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. 3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Exclusion criteria
1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device. 2. Subject has major psychiatric disorder required hospitalization in the last 3 months. 3. Subject has active infection at the site of device application. 4. Subject has recurrent syncope symptoms within the past three months. 5. Subject is pregnant. 6. Subject has had VNS treatment within the past two months. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A modified McGill Pain Questionnaire | at 0,4, weeks of the study, | Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory | at 0,4,8 weeks of the study | Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true. |
| Medical Outcomes Study Sleep Scale | at 0,4,8 weeks of the study | sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time |
| Revised Fibromyalgia Impact Questionnaire | at 0,4,8 weeks of the study | Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact |
| Medical Outcomes Study Questionnaire Short Form 36 | at 0, 4, 8 weeks of the study | Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe. |
| Blood inflammation marker | at 0, 4, 8 weeks of the study | collect blood sample for cytokines level |
| Assessment of gut microbiome changes through genomic phenotypic | at 0, 4, 8 weeks of the study | collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome |
Countries
United States
Contacts
CONTACTLucy Chen, M.D.
CONTACTJianren Mao, M.D.
Outcome results
None listed