taVNS Treatment for Fibromyalgia

Mass General Brigham

Status: Begins enrollment in 1 month

Conditions: Fibromyalgia

Treatments: Device: Auricular transcutaneous electrical nerve stimulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT04777500

2020P003800

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

taVNS Group1

Experimental group

Description:

This group will receive taVNS for 4 weeks.

Treatment:

Device: Auricular transcutaneous electrical nerve stimulation device

taVNS Group 2

Experimental group

Description:

This group will receive taVNS for 4 weeks.

Treatment:

Device: Auricular transcutaneous electrical nerve stimulation device