taVNS Treatment for Fibromyalgia

NCT ID: NCT04777500

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-03

Study Completion Date

2027-03-31

Brief Summary

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In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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taVNS Group1

This group will receive taVNS for 4 weeks.

Group Type EXPERIMENTAL

Auricular transcutaneous electrical nerve stimulation device

Intervention Type DEVICE

We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

taVNS Group 2

This group will receive taVNS for 4 weeks.

Group Type EXPERIMENTAL

Auricular transcutaneous electrical nerve stimulation device

Intervention Type DEVICE

We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Interventions

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Auricular transcutaneous electrical nerve stimulation device

We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
* Willingness to complete a 4-week, twice-a-day treatments.
* At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria

* Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
* Personal history of medical or psychiatric illness as determined by investigator.
* Pregnant or lactating.
* Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Kong

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Maya Eshel, BA

Role: CONTACT

(617) 726-5004

Facility Contacts

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Maya Eshel

Role: primary

Rachel Dao

Role: backup

Other Identifiers

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2020P003800

Identifier Type: -

Identifier Source: org_study_id

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