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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation(tVNS) | Experimental | receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
|
| Sham Control group | No Intervention | receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Device | 30 minutes stimulation, twice per day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| A modified McGill Pain Questionnaire | Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain | at 0,4, weeks of the study, |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 0,4,8 weeks of the study |
| Medical Outcomes Study Sleep Scale |
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Inclusion Criteria:
Exclusion Criteria:
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.
Subject is pregnant.
Subject has had VNS treatment within the past two months.
.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Chen, M.D. | Contact | 617-724-3466 | llchen@mgh.harvard.edu | |
| Jianren Mao, M.D. | Contact | 617-726-2338 | jmao@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31637517 | Result | Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21. | |
| 26364692 | Result | Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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 )
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sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
| at 0,4,8 weeks of the study |
| Revised Fibromyalgia Impact Questionnaire | Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact | at 0,4,8 weeks of the study |
| 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. | at 0, 4, 8 weeks of the study |
| Blood inflammation marker | collect blood sample for cytokines level | at 0, 4, 8 weeks of the study |
| Assessment of gut microbiome changes through genomic phenotypic | collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome | at 0, 4, 8 weeks of the study |
| 33114203 | Result | Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877. |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |