NCT04777500

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
5.6 years until next milestone

Study Start

First participant enrolled

October 3, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

February 17, 2021

Last Update Submit

April 16, 2026

Conditions

Fibromyalgia

Keywords

taVNSPainNeuromodulationFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Revised Fibromyalgia Impact Questionnaire (FIQR)

    A change in the FIQR would indicate that participants are experiencing pain relief.

    Baseline, week 2 and week 4.

Secondary Outcomes (7)

  • Patient Reported Outcomes Measurement Information System (PROMIS-29)

    Baseline, week 2 and week 4.

  • Pain Catastrophizing Scale

    Baseline, week 2 and week 4.

  • Beck Depression Inventory-II (BDI-II)

    Baseline and week 4.

  • Brief Quantitative Sensory Testing (QST)

    Baseline and week 4.

  • Heart rate variability

    Baseline and week 4.

  • +2 more secondary outcomes

Study Arms (2)

taVNS Group1

EXPERIMENTAL

This group will receive taVNS for 4 weeks.

Device: Auricular transcutaneous electrical nerve stimulation device

taVNS Group 2

EXPERIMENTAL

This group will receive taVNS for 4 weeks.

Device: Auricular transcutaneous electrical nerve stimulation device

Interventions

Auricular transcutaneous electrical nerve stimulation deviceDEVICE

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

taVNS Group 2taVNS Group1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129-2020, United States

Location

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jian Kong

    MGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Eshel, BA

CONTACT

(617) 726-5004meshel@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 17, 2021

First Posted

March 2, 2021

Study Start (Estimated)

October 3, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)